The purpose of this long-term follow-up (LTFU) study is to collect delayed adverse events (AEs) and understand the persistence of KYV-101 (autologous CAR T cell product; gene-modified product), in participants who have been administered KYV-101 (gene-modified product; autologous CAR T cell product).
This LTFU protocol will be open to any participant who received at least one infusion of KYV-101 in a previous Kyverna sponsored clinical trial or Investigator Initiated Trial (IIT).

Start Date24 Nov 2025

Sponsor / Collaborator

Kyverna Therapeutics, Inc.

NCT06590545

/ Not yet recruitingPhase 1/2IIT

Anti-CD 19 CAR-T Cell Therapy in Patients with ANCA Vasculitis: a Two-stage Interventional, Prospective, Open-label, Phase I/II Trial in Patients with Active, Treatment Refractory, ANCA-IgG-positive Vasculitis

The goal of this phase I/II clinical trial is to investigate anti-CD 19 chimeric antigen receptor T cell (CAR-T cell) therapy in patients with antineutrophil cytoplasmic antibodies (ANCA) immunoglobulin (IgG) positive ANCA associated vasculitis (AAV).
The main questions it aims to answer are:
* To assess the safety of anti-CD19 CAR-T cell therapy in subjects with active, treatment refractory, ANCA-IgG-positive AAV
* To assess the clinical efficacy of anti-CD19 CAR-T cell therapy in subjects with active, treatment refractory ANCA-IgG-positive AAV
* To assess the ANCA seroconversion rate in subjects with active, treatment refractory ANCA-IgG-positive AAV
Participants will receive a single dose of KYV-101 i.v., an autologous fully-human anti-CD19 CAR-T cell immunotherapy. Follow-up time is 52 weeks with regular visits at the site.

Start Date01 Jan 2025

Sponsor / Collaborator

Kyverna Therapeutics, Inc.

NCT06475495

/ Active, not recruitingPhase 1/2IIT

Comparison of B-cell Depletion by Rituximab and Anti-CD 19 CAR-T Therapy in Patients With Rheumatoid Arthritis. Two-stage Interventional, Prospective, Randomized, Controlled, Open Label, Parallel-group Phase I/II Trial in Patients With Active, ACPA-positive and Treatment Refractory Rheumatoid Arthritis

The goal of this phase I/II clinical trial is to compare B-cell depletion by rituximab and anti-CD 19 CAR-T therapy in patients with rheumatoid arthritis. The main questions it aims to answer are:
* To assess the safety of anti-CD19 CAR T cell therapy in subjects with active, ACPA positive and treatment refractory RA (Phase-I)
* To assess the safety of anti-CD19 CAR T cell therapy and of rituximab in subjects with active, ACPA positive and treatment refractory RA (Phase-II)
* To assess ACPA seroconversion after anti-CD19 CAR T cell or rituximab therapy in subjects with active, ACPA positive and treatment refractory RA (Phase-II)
Participants in the test-arm will receive a single dose of KYV-101 i.v., an autologous fully-human anti-CD19 CAR T-cell immunotherapy. In the comparator group patients will receive 2x1 g Rituximab i.v.
Follow-up time (both arms) is 52 weeks with regular visits at the site.

Start Date04 Dec 2024

Sponsor / Collaborator

Kyverna Therapeutics, Inc.

100 Clinical Results associated with Mivocabtagene Autoleucel(Kyverna)

100 Translational Medicine associated with Mivocabtagene Autoleucel(Kyverna)

100 Patents (Medical) associated with Mivocabtagene Autoleucel(Kyverna)

Literatures (Medical) associated with Mivocabtagene Autoleucel(Kyverna)

01 Dec 2025·Multiple Sclerosis and Related Disorders

CAR T cells for multiple sclerosis: Engineering T cells to disrupt chronic B cell–driven neuroinflammation

Review

Author: Reyes-Mata, María Paulina ; Ortuño-Sahagún, Daniel ; Hermosillo-Abundis, Cristina ; Arias Carrión, Óscar

Chimeric antigen receptor (CAR) T-cell therapy is emerging as a promising approach to overcome the limitations of current B-cell-targeted treatments for multiple sclerosis (MS), particularly in progressive forms where disease-modifying therapies (DMTs) often fail to halt neuroinflammation and disability progression. By penetrating both lymphoid tissues and the central nervous system (CNS), anti-CD19 CAR T cells enable deeper and more durable depletion of autoreactive B cells than monoclonal antibodies. Preclinical studies, including experimental autoimmune encephalomyelitis (EAE) models, support their capacity to induce immune tolerance, suppress demyelinating inflammation, and modulate microglial activation. Experience from the early clinical phase -which currently includes six ongoing trials-demonstrates encouraging safety profiles, CNS trafficking of CAR T cells and evidence of pathogenic B-cell depletion in progressive MS, neuromyelitis optica spectrum disorder (NMOSD), and refractory non-relapsing phenotypes. These include the first-in-human trial CT103A (BCMA-targeted CAR T) in progressive MS and NMOSD (NCT04561557), the detection of CAR T cells in the CNS without ICANS in Anti-CD19 CAR T therapy (NCT06138132), the favorable safety in the multicenter study BMS986353 (NCT06220201), and the confirmed CNS penetration in the UCSF's KYV-101, a CD19 CAR T Cell Therapy study (NCT06451159). Next-generation CAR platforms-including regulatory CAR T cells, brain-targeted safety switches, and antigen-specific modulators-may enhance precision and mitigate neurotoxicity, a critical concern in patients with neurologically vulnerable conditions. However, key challenges remain: the absence of validated CNS-specific antigens, risks such as ICANS, delayed parkinsonian-like syndromes, or progressive multifocal leukoencephalopathy (PML), immune exhaustion within the inflamed CNS, and the logistical demands of autologous cell manufacture. This mini-review synthesizes preclinical and early clinical evidence, outlines translational barriers, and discusses strategies to optimize safety, targeting, and scalability.

01 Nov 2025·Neurology-Neuroimmunology & Neuroinflammation

Anti-CD19 CAR T-Cell Therapy in Advanced Stiff-Person Syndrome and Concomitant Myasthenia Gravis

Article

Author: Motte, Jeremias ; Borie, Dominic ; Lohmann, Clarissa ; Aloizou, Athina-Maria ; Schroers, Roland ; Schneider-Gold, Christiane ; Mika, Thomas ; Faissner, Simon ; Ayzenberg, Ilya ; Gold, Ralf

BACKGROUND:

Autologous chimeric antigen receptor (CAR) T-cell therapy has recently gained interest in the treatment of rheumatic and neuroimmunologic diseases.

METHODS:

We report a 62-year-old female patient with a 14-year history of treatment-refractory anti-GAD-positive stiff-person syndrome (SPS) and concomitant anti-AChR-positive myasthenia gravis. Despite a relatively stable disease course in the first 8 years, SPS dramatically progressed afterward. In 2023, she was able to walk less than 10-15 m and suffered from severe persistent stiffness in the left arm superimposed with painful muscle spasm attacks (MSAs). Numerous immunotherapies, including intravenous immunoglobulins, plasma exchange, steroids, azathioprine, and rituximab, were ineffective. Consequently, she was escalated to compassionate use of autologous anti-CD19 CAR T-cell therapy (KYV-101).

RESULTS:

From the third month post-CAR-T, we observed a substantial improvement in walking distance, pain, anxiety, and MSAs in the arm. By the sixth month, she was able to walk 500 m. The anti-GAD titers declined from 1:320 to 1:32. Side effects included grade 2 cytokine release syndrome and moderate leukopenia, without serious infections.

DISCUSSION:

CAR T-cell therapy was effective at mitigating SPS symptoms, despite the long history and severe refractory disease course in our patient. Controlled trials are needed to evaluate its potential in SPS.

01 Jul 2025·Med

Chimeric antigen receptor T cells in treatment-refractory DAGLA antibody-associated encephalitis

Article

Author: Mougiakakos, Dimitrios ; Haghikia, Aiden ; Schett, Georg ; Gold, Ralf ; Pappa, Vaia ; Motte, Jeremias ; Wickel, Jonathan ; Neyazi, Alexandra ; Faissner, Simon ; Wolleschak, Denise ; Duscha, Alexander ; Böttcher, Martin ; Borie, Dominic ; Geis, Christian ; Hegelmaier, Tobias ; Miske, Ramona ; Desel, Christiane

BACKGROUND:

Autoimmune encephalitides are a heterogeneous group of autoantibody-associated central nervous system disorders. The clinical course of autoimmune encephalitides can be life threatening, and treatment can be challenging.

OBJECTIVE:

This report describes a case of treatment-refractory, anti-diacylglycerol lipase alpha (DAGLA) antibody-associated autoimmune encephalitis successfully treated with chimeric antigen receptor (CAR) T cells.

METHODS:

Treatment was done by single intravenous infusion of fully human, second-generation CAR T cells (KYV-101) targeting CD19 and depleting B cells. Clinical response was measured by International Cooperative Ataxia Rating Scale and Clinical Assessment Scale in Autoimmune Encephalitis scores. Autoantibodies against DAGLA were measured by a recombinant cell-based indirect immunofluorescence assay in the serum and the cerebrospinal fluid and confirmed by staining of primary murine neurons and brain sections.

FINDINGS:

A 36-year-old man developed rapidly progressing generalized myoclonus, cerebellar head tremor, vertical binocular nystagmus, and tetraparesis despite treatment with pulse glucocorticoid therapy, plasma exchange, and rituximab. Anti-DAGLA antibodies were positive in the indirect immunofluorescence assay, in serum and cerebrospinal fluid, and reacted with neurons and brain sections. Due to his severe clinical condition and treatment refractoriness, the patient received a single infusion of autologous anti-CD19 CAR T cells. Clinical scores improved significantly after treatment, and anti-DAGLA antibody levels in serum and cerebrospinal fluid diminished. Oligoclonal bands in the cerebrospinal fluid were initially positive and became negative after CAR T cell therapy.

CONCLUSION:

The report highlights the therapeutic potential of anti-CD19 CAR T cell therapy in severe, treatment-refractory autoimmune encephalitis.

FUNDING:

There was no external funding for the treatment or the data generated.

110

News (Medical) associated with Mivocabtagene Autoleucel(Kyverna)

05 Mar 2026

·www.biospace.com

Kyverna Therapeutics to Present New Data from Neuroimmunology Franchise at AAN 2026

Late-breaking oral presentation to feature primary analysis from KYSA-8 registrational trial in stiff person syndrome (SPS) Oral presentation on updated KYSA-6 Phase 2 data in generalized myasthenia gravis (gMG) EMERYVILLE, Calif., March 05, 2026 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a clinical-stage biopharmaceutical company developing cell therapies for patients with autoimmune diseases, today announced multiple abstracts selected for presentation at the American Academy of Neurology (AAN) Annual Meeting, taking place from April 18-22, 2026, in Chicago, IL. “Our presence at AAN marks an important milestone for Kyverna as we build upon miv-cel’s potential to redefine the treatment paradigm in both stiff person syndrome and myasthenia gravis,” said Warner Biddle, Chief Executive Officer of Kyverna Therapeutics. “The primary analysis from our SPS registrational trial expands on our previously reported positive topline results, which demonstrated statistically significant clinical benefit across all primary and secondary endpoints, including reversing progressive disability. We will also present updated Phase 2 results in myasthenia gravis, seeking to advance our goal of delivering durable, drug-free, disease-free remission with a single dose.” Oral Presentations: Title: Miv-cel CD19 CAR T-Cell Therapy Shows Efficacy and Safety in Stiff Person Syndrome in a Pivotal, Multicenter, Phase 2 Study (KYSA-8) Presenter: Amanda Piquet, M.D., FAAN, University of Colorado Anschutz School of Medicine Date & Time: Tuesday, April 21, 2026, 6:27 PM CT Title: Update on the Phase Two Portion of KYSA-6, an Open-label, Single-arm, Multicenter Study of KYV-101, a Fully Human CD19 Chimeric Antigen Receptor (CAR) T-cell Therapy in Generalized Myasthenia Gravis (gMG) Presenter: Srikanth Muppidi, M.D., Stanford Medicine Date & Time: Monday, April 20, 2026, 1:48 PM CT Poster Presentations: Title: A Multicenter, Real-world Natural History Study on Timed 25-Foot Walk Outcome Measures in Stiff Person Syndrome Presenter: Scott Newsome, D.O., Johns Hopkins Medicine Date & Time: Monday, April 20, 2026, 8:00 AM CT Title: Design of Phase Three of KYSA-6, a Global Open-label, Randomized, Controlled Study of KYV-101, a Fully Human CD19 Chimeric Antigen Receptor (CAR) T-cell Therapy, Versus Ongoing Standard-of-Care (SOC) Immunosuppressive Therapy in Generalized Myasthenia Gravis (gMG) Presenter: Srikanth Muppidi, M.D., Stanford Medicine Date & Time: Tuesday, April 21, 2026, 5:00 PM CT About Stiff Person Syndrome (SPS) SPS is a rare, progressive neurologic autoimmune disease characterized by muscle stiffness and painful muscle spasms, impacting mobility and gait. Stiffness, rigidity, and spasms in the torso, arms, and legs lead to progressive disability causing up to 80% of patients to lose mobility 1-3 . SPS has been shown to lead to permanent disability and increased risk of mortality 3 . Most patients with SPS have antibodies to glutamic acid decarboxylase 65 (GAD65) or the glycine receptor, which disrupt normal inhibitory neurotransmission, contributing to the hallmark symptoms of SPS. There are currently no FDA-approved treatments for SPS. Current treatment options include symptomatic treatments, off-label immunotherapies, such as intravenous immunoglobulin (IVIg), rituximab and plasmapheresis, as well as supportive care and physical, speech, occupational, and psychiatric therapy; however, the majority of patients have inadequate or no response to these treatment options. An estimated 6,000 patients are diagnosed with SPS in the United States 4-5 . About Myasthenia Gravis (MG) Myasthenia gravis is a B-cell and antibody-mediated autoimmune neuromuscular disease that causes muscle weakness and fatigue, and patients may experience difficulty speaking, chewing, swallowing, or breathing. It is caused by autoantibodies produced by B-cells that lead to an immunological attack on critical signaling proteins at the junction between nerve and muscle cells, thereby inhibiting the ability of nerves to communicate properly with muscles. Although symptoms may initially remit, most patients experience progressive disease requiring chronic immunosuppressive therapy. Up to 20% of MG patients experience respiratory crisis at least once in their lives 6 . An estimated 80,000 patients are diagnosed with generalized myasthenia gravis in the United States 7-8 . About miv-cel (mivocabtagene autoleucel, KYV-101) Miv-cel is a fully human, autologous, CD19-targeting CAR T-cell therapy with CD28 co-stimulation, designed for potency and tolerability, which is under investigation for B-cell-driven autoimmune diseases. With a single administration, miv-cel has potential to achieve deep B-cell depletion and immune system reset to deliver durable drug-free, disease-free remission in autoimmune diseases. About Kyverna Therapeutics Kyverna Therapeutics, Inc. (Nasdaq: KYTX) is a clinical-stage biopharmaceutical company focused on liberating autoimmune patients through the curative potential of cell therapy. The Company’s lead autologous CD19-targeting CAR T-cell therapy candidate, miv-cel (mivocabtagene autoleucel, KYV-101), has demonstrated the potential to fundamentally change the treatment paradigm across multiple B-cell-driven autoimmune diseases. Kyverna is advancing its potentially first-in-class neuroimmunology franchise with its initial indications in stiff person syndrome and myasthenia gravis. The Company is also advancing additional clinical and investigator-sponsored studies, including in multiple sclerosis and rheumatoid arthritis, to inform future priority indications and develop next-generation CAR T platforms to improve access and patient experience. For more information, please visit . Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words, without limitation, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Forward-looking statements in this press release include, without limitation, those related to: Kyverna’s anticipated timing for its presentations at the AAN Annual Meeting and the topics expected to be discussed during such presentations; opportunities related to miv-cel, including miv-cel’s potential to redefine the treatment paradigm in both SPS and myasthenia gravis; the expansion of its previously reported topline data; miv-cel’s potential ability to reverse progressive disability miv-cel’s potential to achieve deep B-cell depletion and immune system reset to deliver durable drug-free, disease-free remission in autoimmune diseases in a single dose; and Kyverna’s potentially first-in-class neuroimmunology franchise. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to market conditions, the possibility that results from prior clinical trials, named-patient access activities and preclinical studies may not necessarily be predictive of future results; the possibility that the FDA or other regulatory agencies may require additional trials or studies to support its intended BLA submission; intellectual property rights; and other factors discussed in the “Risk Factors” section of Kyverna’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q that Kyverna has filed or may subsequently the U.S. Securities and Exchange Commission. Any forward-looking statements contained in this press release are based on the current expectations of Kyverna’s management team and speak only as of the date hereof, and Kyverna specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Contact: Investors:  InvestorRelations@kyvernatx.com Media:  media@kyvernatx.com 1 Rakocevic G, et al. BMC Neurol. 2019;19:1. 2 Dalakas MC. Nat Rev Neurol. 2024;20(10):587-601. 3 Duddy ME, Baker MR. Front Neurol Neurosci. 2009;26:147-165. 4 Crane PD, et al. Neurology. 2024;103(12):e210078. 5 Analysis of 2024 Komodo U.S. Claims Data. 6 Claytor B, et al. Muscle Nerve. 2023;68(1):8-19. 7 Rodriguez E, et al. Muscle. Nerve. 2024;69(2):166-171. 8 Hendricks TM, et al. Am J Opthamol. 2019; 205:99-105. 3. Clarivate DRG Report (2024).

Clinical ResultCell TherapyPhase 2ImmunotherapyPhase 3

04 Mar 2026

·allsci.com

UCB bags Antengene’s CD19/CD3 bispecific TCE for autoimmune diseases for up to USD 1.3b

Hong Kong-headquartered Antengene Corporation and Brussels-based UCB (Euronext Brussels) announced a global license agreement granting UCB worldwide exclusive rights to develop, manufacture, and commercialize ATG-201, a CD19/CD3 bispecific T-cell engager antibody targeting B cell-related autoimmune diseases. For UCB, the deal represents a return to B cell-targeting strategies in the immunology space. UCB gains access to the manufacturing technology related to ATG-201, while Antengene will lead on IND filings for the molecule and initiation of first-in-human Phase I studies in China and Australia before transferring further clinical development to UCB. Antengene will receive USD 60 million upfront and USD 20 million in near-term milestone payments, totaling USD 80 million in upfront and near-term consideration. The company is eligible for over USD 1.1 billion in success-based development, regulatory, and sales milestones, along with tiered royalties on future net sales. The deal is structured as a full global out-license, with Antengene retaining no long-term territorial commercialization rights. Deal context ATG-201 is a bispecific antibody built on Antengene’s proprietary AnTenGager platform, which uses a “2+1” format — two CD19 binding arms and one CD3 binding arm — combined with steric hindrance masking technology and a proprietary fast-on-fast-off CD3 binder. The molecule is designed to redirect T cells to eliminate CD19-expressing B cells while reducing the risk of cytokine release syndrome. Antengene plans to submit clinical trial applications for ATG-201 in China and Australia in Q1 2026. The asset is pre-Phase I, with no clinical trial registry entries publicly available at the time of announcement. For UCB, the deal adds a B cell autoimmune therapy modality to an immunology pipeline historically built on monoclonal antibodies and other biologics. UCB previously pursued CD22-targeted B cell depletion through an epratuzumab collaboration with Immunomedics, structured in 2009 with approximately USD 38 million upfront and later restructured in 2011; that program was ultimately discontinued. The ATG-201 agreement represents a return to B cell-targeting strategies, this time via a T-cell engager format. No prior deals between Antengene and UCB were identified; this is the first transaction between the two companies. For Antengene, the transaction represents a shift from its historical pattern of in-licensing Western assets for Asia-Pacific development — such as its selinexor license from Karyopharm Therapeutics — to out-licensing a proprietary, platform-derived candidate to a global pharma company. Nine additional disclosed products remain in the AnTenGager pipeline. The Antengene transaction comes amid rising industry investment in T-cell engager therapies targeting B-cell biology in autoimmune diseases. In January 2025, Merck acquired global ex-China rights to Curon Biopharmaceutical’s CD19×CD3 bispecific antibody CN201 in a deal worth up to USD 1.3 billion, including USD 700 million upfront. Candid Therapeutics is another TCE specialist focused on autoimmune programs, and recently merged with Rallybio gaining USD 505 million in new financing, with programs targeting BCMA, CD20, and CD19/CD20 combinations. The modality also has precedent in oncology through Amgen’s CD19/CD3 bispecific blinatumomab (Blincyto), which is currently being evaluated in a Phase II autoimmune disease study (NCT06570798) in systemic lupus erythematosus and rheumatoid arthritis. Meanwhile, CD19 CAR-T therapies for autoimmune disease include Kyverna Therapeutics’ KYV-101, currently Phase 2 for lupus nephritis. The UCB license agreement positions the company within this competitive set, though ATG-201’s differentiated platform design — incorporating conditional T-cell activation via steric masking — may address tolerability concerns that have limited earlier CD19/CD3 bispecific T-cell engager approaches. ATG-201 remains at an early development stage, and clinical data will be required to confirm whether the platform’s design translates into a differentiated safety and efficacy profile relative to both CAR-T and other TCE modalities targeting autoimmune diseases indications. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

License out/inPhase 1Phase 2Immunotherapy

03 Feb 2026

·www.fiercebiotech.com

FDA signals tailored approach to ‘carefully shepherd’ CAR-T therapy for autoimmune diseases

While the FDA “shares enthusiasm” for CAR-T therapies in autoimmune diseases, the agency will “carefully shepherd” the advancement of clinical studies, the FDA’s Vinay Prasad and colleagues said in an Annals of Internal Medicine article.\n As the first CAR-T treatment for an autoimmune disease draws ever closer, officials at the FDA have signaled a willingness to support the development of these novel cell therapies with a flexible regulatory approach.While interested in CAR-T therapies’ potential to achieve durable, drug-free remission in serious autoimmune conditions, the FDA is equally wary of their “unpredictable long-term toxicity,” according to an article published Monday in the Annals of Internal Medicine.In the article, Vinay Prasad, M.D., director of the FDA’s Center for Biologics Evaluation and Research, and two other regulators said that, recognizing the complexity of autoimmune conditions in terms of seriousness and type, the agency will work with CAR-T makers “on a case-by-case basis to encourage appropriate study populations in rheumatologic autoimmune disease.”Simultaneously, citing a need to monitor a drug’s effect on fertility, the FDA officials recommended that industry conduct long-term follow-up studies for CAR-T products in the autoimmune setting, “as is standard for genetic therapies and CAR T-cells for oncologic indications.”While the FDA “shares enthusiasm for this class of products,” it will “carefully shepherd” the advancement of clinical studies “focused on the development, durability, and long-term safety of CAR T-cell therapies,” the regulators wrote.Publication of the FDA’s perspective comes as the first CAR-T therapy for an autoimmune disease could arrive soon in the form of Kyverna Therapeutics’ mivocabtagene autoleucel (miv-cel). After reporting positive pivotal clinical trial results in December, the California biotech is targeting an FDA application for the CD19-directed CAR-T cell therapy for the treatment of stiff person syndrome (SPS) in the first half of 2026. Kyverna has said it is aligned with the FDA on its registrational trial design. The new article “does not change our strategy or impact our clinical development plans,” a Kyverna spokesperson told Fierce, adding that the company already has long-term patient monitoring in place. The December readout from the registrational KYSA-8 trial evaluated miv-cel’s treatment effect after 16 weeks of treatment, with patients planned to be followed for a year.Kyverna’s KYSA-8 study enrolled SPS patients who had had an inadequate response to prior immunomodulatory therapies. Because of potential long-term toxicity, the FDA has generally encouraged drugmakers to develop CAR-T meds for patients with refractory disease who have failed at least two previous immunosuppressants, Prasad and colleagues noted in the article.However, this restriction may be inappropriate for patients with severe disease, given the high risk for irreversible organ damage, the FDA officials acknowledged. Therefore, the regulators suggested a case-by-case development plan.CAR-T therapies were initially developed for blood cancers. While highly efficacious at staving off diseases such as large B-cell lymphoma and multiple myeloma, these one-time treatments may carry the risk of late-onset side effects such as Parkinson’s disease and secondary T-cell cancer. These products were approved with the FDA’s requirement to conduct observational studies for 15 years to assess their secondary cancer risks over the long term.In the Feb. 3 article, Prasad and colleagues didn’t specify how long the FDA is asking autoimmune CAR-T trials to be followed. Based on precedents with cancer CAR-T meds, having long-term data is a post-market commitment rather than a condition for approval.“We don’t think the views in this paper are substantively different than current practice,” Stephen Majors, VP of global communications and investor relations at Alliance for Regenerative Medicines, said in a statement to Fierce. “However, we would encourage the FDA to periodically review the requirement for 15 years of follow-up on all CAR-T products in light of new evidence emerging over time.”Enthusiasm for turning CAR-T therapies against autoimmune diseases was ignited in 2021 after researchers in Germany reported a patient with severe systemic lupus erythematosus who achieved rapid, drug-free remission after receiving anti-CD19 CAR-T cells. The idea is that these immunotherapies may eradicate autoreactive B cells that drive autoimmune diseases. In September, the same German team, led by Georg Schett, M.D., from the University of Erlangen-Nuremberg, reported long-term data for 11 patients with refractory SLE who had been followed up by a median of two and a half years or up to four years. All patients remained in a sustained, drug-free remission despite one SLE flare. The team also pointed to a better safety profile of the CAR-T therapy compared with the lymphoma setting.Of the limited number of patients treated with autoimmune CAR-T drugs to date, no secondary malignancies have been publicly reported.In an email to Fierce, Schett argued that T-cell lymphoma risk in autoimmune disease is “not an issue.”Unlike B-cell lymphoma, autoimmune disease does not come with an increased underlying risk for secondary T-cell cancer, he noted. In blood cancer treatment, recipients of CAR-T cells typically have received extensive, toxic prior therapies, which are major drivers of secondary cancers. In contrast, patients with autoimmune disease are often treated with immunosuppressants and generally have not been exposed to the same volume of highly genotoxic agents as oncology patients.The possibility of the genetic material of the CAR receptor being integrated into the human genome gives rise to concerns of secondary malignancies. But in autoimmune patients, the CAR-T cells do not live long, Schett noted.Unlike in oncology, where CAR-T cells often must persist to keep cancer at bay, the therapeutic goal in autoimmune diseases like SLE is often to quickly deplete the problematic B cells and therefore reset the immune system.

ImmunotherapyClinical ResultCell TherapyClinical Study

100 Deals associated with Mivocabtagene Autoleucel(Kyverna)

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Lupus Nephritis	Phase 3	United States	Kyverna Therapeutics, Inc.	26 Feb 2026
Lupus Nephritis	Phase 3	Brazil	Kyverna Therapeutics, Inc.	26 Feb 2026
Lupus Nephritis	Phase 3	Germany	Kyverna Therapeutics, Inc.	26 Feb 2026
Rheumatoid Arthritis	Phase 3	United States	Kyverna Therapeutics, Inc.	26 Feb 2026
Rheumatoid Arthritis	Phase 3	Brazil	Kyverna Therapeutics, Inc.	26 Feb 2026
Rheumatoid Arthritis	Phase 3	Germany	Kyverna Therapeutics, Inc.	26 Feb 2026
Scleroderma, Systemic	Phase 3	United States	Kyverna Therapeutics, Inc.	26 Feb 2026
Scleroderma, Systemic	Phase 3	Brazil	Kyverna Therapeutics, Inc.	26 Feb 2026
Scleroderma, Systemic	Phase 3	Germany	Kyverna Therapeutics, Inc.	26 Feb 2026
Stiff-Person Syndrome	Phase 3	United States	Kyverna Therapeutics, Inc.	26 Feb 2026

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06193889 (KYSA-6, Tandem Meetings ASTCT and CIBMTR2026)	Phase 2	Myasthenia Gravis AChR \| MuSK autoantibodies	5	KYV-101 (AChR or MuSK autoantibodies + generalized myasthenia gravis)	mupcfnjgfa(prrawvderd) = ygqxnzkjxh ewgkmvfxzy (sbzlintifu ) View more	Positive	04 Feb 2026
NCT06588491 (KYSA-8, Company_Website) Manual	Phase 2	Stiff-Person Syndrome	26	Miv-cel	hqingknqou(ciigzmrubh) = etvhrjlllj gdydtkpdib (nwpslmnhcc ) Met	Positive	15 Dec 2025
NCT06193889 (KYSA-6, GlobeNewswire) Manual	Phase 2/3	Myasthenia Gravis	6	KYV-101	wachstgqdf(ojlmozphqv) = rrupxchhwj jdutiucano (cbqveogtgx ) View more	Positive	29 Oct 2025
NCT06342960 \| NCT05938725 (KYSA-3, PRNewswire) Manual	Phase 1/2	Lupus Nephritis	6	KYV-101	lvpvbsycbx(yfktavycyt) = No High-Grade CRS or ICANS Observed. bderqmhejs (aqhvexzcqx ) View more	Positive	14 Nov 2024
Company_Website Manual	Not Applicable	Multiple Sclerosis \| Myasthenia Gravis \| Neuroinflammatory Diseases ... View more	41	KYV-101	uvpbchakey(nimyixxjgh) = In stiff-person syndrome, two patients treated with KYV-101 have demonstrated improved mobility and/or walking speed and reduced autoantibody titers, including one patient at greater than one year post-infusion. A third patient demonstrated reduced autoantibody titers but does not yet have mobility scores available. In myasthenia gravis, three patients treated with KYV-101 have shown reduced pathogenic anti-AChR antibody titers and sustained disease control, including two patients at more than one year post-infusion and all three at greater than 8 months post-infusion. In multiple sclerosis, five patients treated with KYV-101 who failed prior anti-CD20 medications have shown a significant and unprecedented average reduction in oligoclonal bands in the central nervous system (CNS), a potential surrogate biomarker for reduced disease progression. xwqljtjkjb (mioznxnwzf ) View more	Positive	18 Sep 2024
PRNewswire Manual	Not Applicable	Stiff-Person Syndrome	1	KYV-101	ihjmygchbq(kczlhjrodk) = ugctrzfnlz sciqhadurw (pljfsnqvzu )	Positive	17 Jun 2024
NEWS 1 \| NEWS 2	Not Applicable	Lupus Nephritis	50	KYV-101	gqukczhkay(cqxadyjtwx) = xxvqwhpiba riowimkywk (uhawgwknif )	Positive	14 Jun 2024
PRNewswire Manual	Not Applicable	Myasthenia Gravis	1	KYV-101	jkenddzvix(czozsqscfl) = pgikauifiw fakuszoemr (qtkcwhujht ) View more	Positive	15 Nov 2023
NCT02659943 (CTgov)	Phase 1	Chronic Lymphocytic Leukemia \| B-Cell Lymphoma \| Diffuse Large B-Cell Lymphoma	27	Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells (LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only)	sosmgbzbgy = odvabzynak hprhbjvdsx (itauqoezzs, hdyfwcavjd - ksumatbtoo) View more	-	04 May 2021
NCT02659943 (CTgov)	Phase 1		27	Fludarabine+Cyclophosphamide+Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells (LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells)	sosmgbzbgy = slkcmhxgwx hprhbjvdsx (itauqoezzs, snamnvwucy - rbkbjxburi) View more	-	04 May 2021

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