[Translation] Long-term follow-up study of a phase Ib/II clinical study of anti-CD19/CD20 chimeric antigen receptor autologous T cell injection (C-CAR039) in the treatment of CD19 or CD20 positive relapsed or refractory large B-cell lymphoma

1)评价C-CAR039治疗复发或难治性大B细胞淋巴瘤（LBCL）受试者的长期安全性；2)评价C-CAR039治疗复发或难治性LBCL受试者的长期生存情况；3）评价C-CAR039细胞制剂长期的药代动力学；4）评价C-CAR039治疗复发或难治性LBCL受试者的长期免疫原性；5）评价C-CAR039治疗复发或难治性LBCL受试者的长期疗效（入组时处于缓解状态的受试者）。

[Translation]

1) Evaluate the long-term safety of C-CAR039 in the treatment of subjects with relapsed or refractory large B-cell lymphoma (LBCL); 2) Evaluate the long-term survival of subjects with relapsed or refractory LBCL treated with C-CAR039; 3) Evaluate the long-term pharmacokinetics of C-CAR039 cell preparations; 4) Evaluate the long-term immunogenicity of C-CAR039 in the treatment of subjects with relapsed or refractory LBCL; 5) Evaluate the long-term efficacy of C-CAR039 in the treatment of subjects with relapsed or refractory LBCL (subjects in remission at the time of enrollment).

Start Date21 Jun 2023

Sponsor / Collaborator

Shanghai Cellular Biopharmaceutical Group Ltd.

NCT05800977

/ RecruitingPhase 1/2

A Phase 1b/2 Study of a Anti-CD19/CD20 Bispecific CAR-T Therapy (C-CAR039/Prizloncabtagene Autoleucel) in Patients with Relapsed/Refractory Large B-Cell Lymphoma

This is a multicenter, single arm, open-label study. The purpose of the study is to evaluate safety of Prizloncabtagene Autoleucel (Prizlon-cel) and establish the recommended Phase 2 dose (RP2D) (Phase 1b) and to evaluate the efficacy of Prizlon-cel (Phase 2) in patients with relapsed or refractory large b-cell lymphoma (LBCL).

Start Date22 Feb 2023

Sponsor / Collaborator

Shanghai Cellular Biopharmaceutical Group Ltd.

NCT05421663

/ RecruitingPhase 1

A Phase 1b Multicenter, Open-Label, Study of JNJ-90014496, an Autologous CD19/CD20 Bi-specific CAR-T Cell Therapy in Adult Participants With B-Cell Non-Hodgkin Lymphoma

This is a Phase Ib multicenter, open-label study of JNJ-90014496, an autologous bi-specific chimeric antigen receptor (CAR) T-cell therapy, targeting both cluster of differentiation (CD) CD19 and CD20 for the treatment of adult participants with B-Cell non-Hodgkin lymphoma (B-NHL).

Start Date12 Aug 2022

Sponsor / Collaborator

Janssen Research & Development LLC

100 Clinical Results associated with Prizloncabtagene autoleucel

100 Translational Medicine associated with Prizloncabtagene autoleucel

100 Patents (Medical) associated with Prizloncabtagene autoleucel

Literatures (Medical) associated with Prizloncabtagene autoleucel

03 Apr 2025·BLOOD

A phase 1 trial of prizloncabtagene autoleucel, a CD19/CD20 CAR T-cell therapy for relapsed/refractory B-cell non-Hodgkin lymphoma

Article

Author: Yang, Min ; Yao, Yihong ; Zhang, Yan ; Yao, Xin ; Ye, Shiguang ; Lan, Liping ; Zhao, Jing ; Zhou, Lili ; Zheng, Chengxiao ; Li, Lanfang ; Zhu, Kevin ; Wan, Hui ; Li, Jing ; Zhu, Dan ; Liang, Aibin ; Yu, Wenjuan ; Zhang, Huilai ; Zhou, Daobin ; Li, Ping ; Huang, Jiaqi ; Jin, Jie

Abstract:

Prizloncabtagene autoleucel (prizlon-cel), a novel bispecific chimeric antigen receptor T cell, targets and eliminates CD19/CD20-positive tumor cells. This phase 1, open-label study investigated the safety and efficacy of prizlon-cel in patients with relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL). Patients with CD19 and/or CD20-positive R/R B-NHL received a 3-day lymphodepletion (cyclophosphamide: 300 mg/m2 per day; fludarabine: 30 mg/m2 per day) followed by an IV dose of prizlon-cel. The primary end points were dose-limiting toxicity (DLT) and incidence and severity of treatment-emergent adverse events (TEAEs). Secondary end points included overall response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS). Of the 48 patients infused prizlon-cel, 44 had large B-cell lymphoma (LBCL). No patient experienced DLT. Cytokine release syndrome occurred in 93.8% of the patients, with only 1 case of grade 3. Immune effector cell-associated neurotoxicity syndrome occurred in 6.3% of patients, with no grade 3 or higher events. The most common grade 3 or higher TEAEs were neutropenia (83.3%) and leukopenia (50%). The ORR and complete response (CR) rates in all patients were 91.5% and 85.1%, respectively, and in LBCL patients, ORR was 90.7% with 86.0% CR. With median follow-up of 30.0 months, median DOR, PFS, and OS were all not reached. Kaplan-Meier estimate of 2-year DOR, PFS, and OS rates were 66.0%, 62.6%, and 76.5%, respectively. Prizlon-cel had a favorable safety profile and a high and durable response in patients with R/R B-NHL, suggesting a promising treatment option for patients with R/R B-NHL. These trials were registered at www.clinicaltrials.gov as #NCT04317885, #NCT04655677, #NCT04696432, and #NCT04693676.

03 Apr 2025·BLOOD

Prizloncabtagene autoleucel: a new CAR T cell for B-NHL

Communications

Author: Sureda, Anna ; Mussetti, Alberto

News (Medical) associated with Prizloncabtagene autoleucel

16 Jun 2025

·www.prnewswire.com

AbelZeta Announces Promising Long-Term Outcomes for C-CAR039, a Novel CD19/CD20 Bi-Specific CAR-T Therapy, in Patients with R/R B NHL at EHA 2025

MILAN, June 16, 2025 /PRNewswire/ -- AbelZeta Pharma, Inc. ("AbelZeta" or the "Company"), a global clinical-stage biopharmaceutical company focused on discovery and development of innovative and proprietary cell-based therapeutic products, presented promising four-year clinical outcomes from 48 relapsed or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL) patients treated with C-CAR039 (also known as Prizloncabtagene Autoleucel) in greater China, at the European Hematology Association (EHA) 2025 Congress. The study evaluated the safety and efficacy of C-CAR039, a novel anti-CD19/CD20 bi-specific CAR-T therapy. The dual-targeting approach to both CD20 and CD19 antigens aims to enhance therapeutic efficacy and reduce the likelihood of antigen escape, a common mechanism of resistance in B-cell malignancies. Key Findings: The overall response rate (ORR) and complete response (CR) rate were 91.5% and 85.1%, respectively for all patients Among the 43 LBCL pts, ORR and CR were 90.7% and 86.0%, respectively With a median follow-up of 45.5 months (range, 3.1–62.8), the median duration of response (DOR), progression-free survival (PFS), and overall survival (OS) were not reached KM estimates of 48-m PFS rate are 52.5% for all patients and 53.4% for LBCL patients, respectively KM estimates of 48-m OS rate are 65.4% for all patients and 66.7% for LBCL patients, respectively Safety Highlights: CRS of any grade: 93.8% | Grade ≥3: 2.1% ICANS of any grade: 6.3% | No severe cases (Grade ≥3) reported No new safety signals were observed with longer follow-up C-CAR039 has continued to show an excellent safety profile and deep and durable responses in R/R B-NHL patients, especially in those with R/R LBCL. These results continue to provide strong support for the curative potential of C-CAR039 as a next-generation therapy for R/R B-NHL. Late-stage clinical development is ongoing. "The long-term clinical outcomes data for C-CAR039 are highly encouraging, demonstrating sustained responses in patients with relapsed or refractory B-cell non-Hodgkin lymphoma," said Tony (Bizuo) Liu, Chairman and Chief Executive Officer of AbelZeta. "These results underscore our commitment and corporate goal to develop transformative therapies that address significant unmet medical needs in cancer." Dr. Yihong Yao, Chief Scientific Officer of AbelZeta, commented, "The strong clinical results of C-CAR039 demonstrate the added value of targeting CD20 in addition to CD19 in aggressive B-NHL. By addressing the limitations of single-antigen therapies - such as CD19 antigen escape - C-CAR039 enables deeper tissue penetration and more complete B-cell depletion. The durable responses observed support the continued advancement of C-CAR039 as a promising new treatment for patients with aggressive B-cell malignancies." For more information on the study and access to the poster presentation, please visit the EHA Library poster here. AbelZeta previously presented 30-month Phase 1 clinical trial results at the 65th American Society of Hematology (ASH) Annual Meeting in December 2023, through oral presentation #1025, as well as at EHA 2024, through poster presentation #P1475. The data with 30 months follow up was published in Blood 2025 Apr 3;145(14):1526-1535. AbelZeta Inc. (formerly known as Cellular Biomedicine Group, Inc.), entered into a worldwide collaboration and licensing agreement with Johnson & Johnson* in 2023 to develop and commercialize next-generation CAR-T cell therapies (excluding Greater China). The Phase 1 study for C-CAR039 was conducted by AbelZeta in China for the treatment of patients with B-cell non-Hodgkin lymphoma. Johnson & Johnson is evaluating the safety and efficacy of this asset (known as JNJ-90014496 outside of Greater China) through a separate study involving a global patient population. Phase 1b data for JNJ-90014496 were presented at EHA 2025 on Friday, June 13, informing the recommended Phase 2 dose and an initial assessment of safety, efficacy and pharmacokinetics in R/R LBCL patients. For more information, please visit Johnson and Johnson website: . *The legal entity to the worldwide collaboration and license agreement is Janssen Biotech, Inc., a Johnson & Johnson company. About AbelZeta Pharma, Inc. AbelZeta is a global clinical-stage biopharmaceutical company with centers of excellence in Rockville, Maryland and Shanghai, China. AbelZeta is focusing on developing innovative and proprietary cell-based therapeutic products and is committed to ushering in bespoke treatments that harness the body's own immune system to fight against hematological malignancies and solid tumors, as well as inflammatory and immunological diseases. AbelZeta advances research and development in its own GMP facilities at its centers of excellence for early-stage clinical studies, with a pipeline comprised of CAR-T therapies. Forward-Looking Statements Statements in this communication relating to plans, strategies, specific activities, and other statements that are not descriptions of historical facts are forward-looking statements. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include any risks detailed from time to time in the Company's reports. Such statements are based on the management's current beliefs and expectations and are subject to significant risks and uncertainties outside of management and the Company's control. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as otherwise required by law, the Company does not undertake any obligation, and expressly disclaims any obligation, to update, alter or otherwise revise any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise. Company Contact: Sarah Kelly Director of Communications AbelZeta Pharma, Inc. +1 (240) 552 5870 [email protected] SOURCE AbelZeta Pharma, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

License out/inCell TherapyPhase 1Clinical ResultASH

16 Jun 2025

·www.biospace.com

J&J’s Dual-Targeting CAR T Hits 80% Complete Response in Early Lymphoma Study

iStock, Sundry Photography Analysts at Truist Securities called J&J’s CAR-T readout “compelling,” noting that the efficacy figures could position the cell therapy as a formidable competitor to the current standard of care, Gilead’s Yescarta. Johnson & Johnson ’s investigational CAR T therapy JNJ-4496 elicited a treatment response in up to 100% of dosed patients with large B cell lymphoma, posing a challenge to Gilead’s current standard of care Yescarta. Data from the Phase Ib trial , presented at the 2025 congress of the European Hematology Association on Friday, showed a 100% objective response rate (ORR) in patients with relapsed or refractory disease who had undergone one prior line of therapy. Complete response (CR) in this subgroup was 80%. In patients who had received two or more treatments, JNJ-4496’s ORR and CR rates dipped slightly to 92% and 75%, respectively. In an investor note on Saturday, Truist Securities called these data “compelling,” noting that they represent an “encouraging step up from the current standard of care, Yescarta.” For instance, in the second-line setting, Yescarta, a CAR T manufactured by Kite, showed a 65% CR, dropping to 36% in the third-line, according to the analysts. “High CR rates in a cross-trial [comparison] vs Yescarta were observed regardless of prior lines of therapy,” Truist added, however noting that JNJ-4496’s true edge was in safety. The Phase Ib study documented no cases of grade 3 or 4 cytokine release syndrome, a common adverse effect in immunotherapies. However, 84% of patients developed grade 3 or 4 treatment-emergent serious adverse events, the most of which was neutropenia, or low levels of a type of white blood cell. “The safety pro superior than Yescarta,” according to the Truist analysts, who added that JNJ-4496’s safety at the recommended Phase II dose “shows improvement over 1st gen CAR-Ts.” Friday’s readout comes as J&J works to maintain its leadership in the CAR T space, particularly as competitor Gilead builds up to a 2026 multiple myeloma launch of anitocabtagene autoleucel (anito-cel), its challenge to J&J and Legend Biotech’s Carvykti. Last month, Gilead’s partner Arcellx disclosed Phase II data showing a 97% ORR for anito-cel in patients with relapsed or refractory multiple myeloma at the fourth-line or later setting. CR was 68%. At the time, BMO Capital Markets wrote that anito-cel’s efficacy was “at a minimum comparable to Carvykti, with potentially better [overall survival] rates.” JNJ-4496 is an investigational CAR-T therapy that came under J&J’s fold in May 2023 when the pharma paid $245 million upfront —and promised an undisclosed amount in milestones, plus tiered royalties—to partner with the Shanghai-based AbelZeta Pharma (which at the time was still named Cellular Biomedicine Group). The molecule works by binding to both the CD19 and CD20 proteins, both of which are commonly found on malignant B cells, in turn leading to their destruction. According to J&J’s release on Friday, JNJ-4496 also carries a 4-1BB costimulatory domain, which is “intended to enhance binding strength and persistence” and surmount common pathways of treatment resistance.

Clinical ResultImmunotherapyCell TherapyPhase 1Phase 2

13 Jun 2025

·www.fiercebiotech.com

J&J ties early-stage lymphoma CAR-T to 100% response rate in 10 patients

Johnson & Johnson’s autologous CAR-T targets both CD19 and CD20, cell surface proteins commonly expressed by cancerous B cells.\n Johnson & Johnson is providing a first look at clinical data for its dual-targeting blood cancer CAR-T program. In a phase 1b trial of patients with relapsed or refractory large B-cell lymphoma, 22 patients who received the recommended phase 2 dose of the CAR T were included in the efficacy data with a median follow-up of four months. Of the 10 patients who had received one line of prior treatment, an objective response rate (ORR) of 100% was recorded, and all signs of cancer were undetectable for eight of the patients, J&J announced in a June 13 release.For 12 patients who had received two or more previous therapies, the ORR was 92% and the complete response rate was 75%, the New Jersey company said.In the trial’s 25-patient safety arm, 84% of patients had grade 3 or 4 treatment-related adverse events, with 28% experiencing serious side effects.Within the cohort, there were no cases of grade 3 or 4 cytokine release syndrome, the healthcare giant said. One patient experienced grade 1 immune effector cell-associated neurotoxicity syndrome (ICANS), while another patient with central nervous system lymphoma experienced grade 3 ICANS.The phase 1b trial’s primary endpoints are the occurrence of adverse events, including dose-limiting toxicities, and the determination of the recommended phase 2 dose, which J&J said in the release was 75 million CAR T cells. J&J did not mention dose-limiting toxicities in the release.J&J presented the data at the 2025 European Hematology Association conference in Milan. A global, open-label component of the phase 1b study is still ongoing. The autologous CAR-T targets both CD19 and CD20, cell surface proteins commonly expressed by cancerous B cells.“Only about 40% of patients have long-term remissions with currently available single-antigen-targeting CD19 CAR T therapies,\" Krish Patel, M.D., director of lymphoma research at the Nashville, Tennessee-based Sarah Cannon Research Institute and principal investigator of the study, said in the release. \"The data presented today show encouraging clinical activity and promising safety, and represent a step forward in delivering a potential new treatment option to patients living with the most common type of aggressive lymphoma.\"JNJ-4496 came to J&J through a 2023 collaboration and licensing agreement with Chinese-American biotech AbelZeta (formerly Cellular Biomedicine Group). Through that deal, J&J’s pharma unit Janssen paid $245 million upfront for the ex-China rights to JNJ-4496 (called C-CAR039 in China) and another CD20-targeting CAR T called C-CAR066.The AbelZeta deal marked J&J’s return to the CAR-T field after the 2022 approval of Legend Biotech-partnered Carvykti. While competitors such as Novartis, Gilead Sciences and AstraZeneca were pushing forward in the area at the time, J&J chose to hang back until the right opportunity came along.The cell therapy field has since been thinning out amid high costs and clinical struggles. Cell therapy biotechs like Carisma Therapeutics and Vor Bio announced they were shutting down earlier this year, while CAR-T company Cargo Therapeutics dumped all of its assets and laid off 90% of its staff in March.

Phase 1Cell TherapyClinical ResultImmunotherapyLicense out/in

100 Deals associated with Prizloncabtagene autoleucel

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10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diffuse Large B-Cell Lymphoma	Phase 2	China	Shanghai Cellular Biopharmaceutical Group Ltd.	22 Feb 2023
Mediastinal large B-cell lymphoma	Phase 2	China	Shanghai Cellular Biopharmaceutical Group Ltd.	22 Feb 2023
High grade B-cell lymphoma	Phase 1	United States	Janssen Research & Development LLC	12 Aug 2022
High grade B-cell lymphoma	Phase 1	Australia	Janssen Research & Development LLC	12 Aug 2022
High grade B-cell lymphoma	Phase 1	Canada	Janssen Research & Development LLC	12 Aug 2022
High grade B-cell lymphoma	Phase 1	Denmark	Janssen Research & Development LLC	12 Aug 2022
High grade B-cell lymphoma	Phase 1	Netherlands	Janssen Research & Development LLC	12 Aug 2022
High grade B-cell lymphoma	Phase 1	Spain	Janssen Research & Development LLC	12 Aug 2022
High grade B-cell lymphoma	Phase 1	United Kingdom	Janssen Research & Development LLC	12 Aug 2022
Refractory Mature B-Cell Non-Hodgkin Lymphoma	Phase 1	United States	Janssen Research & Development LLC	12 Aug 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04693676 \| NCT04655677 \| NCT04317885 \| NCT04696432 (Pubmed) Manual	Phase 1	Non-Hodgkin Lymphoma CD20 Positive \| CD19 Positive	48	Prizloncabtagene autoleucel	prsmierpqj(tlijdkivsb) = mphcklsvut mgercssofu (oraxrfpiyi ) View more	Positive	15 Jan 2025
	Phase 1	Non-Hodgkin Lymphoma CD20 Positive \| CD19 Positive	48	Prizloncabtagene autoleucel (Large B-cell lymphoma (LBCL))	qyfvklcqpk(iavrhjhloc) = wxuesncgsj zvgwdfjvnq (apugjwucom ) View more	Positive	15 Jan 2025
NCT04693676 \| NCT04655677 \| NCT04317885 \| NCT04696432 (C-CAR039, EHA2024)	Phase 1	B-cell lymphoma refractory CD20 \| CD19	48	C-CAR039	vmqvglsqwt(yeiaufxuwj) = emmqvunebq jpsibxacwu (ljcavnvnyi ) View more	Positive	14 May 2024
CTR20250125 (ASH2023) Manual	Not Applicable	B-Cell Lymphoma	48	C-CAR039	bvcissgegm(tzuikeyggo) = ucxmhikmix fzydnlmjzh (oyqzgfheed ) View more	Positive	11 Dec 2023
NCT04317885 (ASCO2021)	Phase 1	B-cell lymphoma refractory	28	C-CAR039	lxglrwznvy(uekqvobqif) = qoqfngpiwy jvqixnfdxe (nmqnglthep ) View more	-	28 May 2021
NCT04317885 (ASH 12020 \| ASH 22020) Manual	Phase 1	B-Cell Lymphoma	16	cyclophosphamide+fludarabine+C-CAR039	kljdvoxrht(vjaeohwcyh) = Reversible CRS was observed in 12 (86%) of patients crdvxtvhuc (hypibpkueg ) View more	Positive	05 Nov 2020

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