This study is a Phase 1/2 dose-finding and dose-confirmation study to evaluate the safety and antitumor activity of UB-VV400. The study will enroll patients with relapsed/refractory B-cell malignancies, including large B-cell lymphoma (LBCL).

Start Date01 Nov 2026

Sponsor / Collaborator

Umoja Biopharma, Inc.

NCT06743503

/ RecruitingPhase 1

An Exploratory, Open-label Study of UB-VV400 in Combination With Rapamycin in Relapsed or Refractory B-cell Malignancies

This is an exploratory, open-label, investigator-initiated trial (IIT) of the safety, efficacy, and PK/Pd of UB-VV400 alone and in combination with rapamycin in adult subjects with R/R LBCL. LBCL will include subjects with aggressive lymphoma, defined as diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), including high-grade lymphoma (HGL) with double/triple hit DLBCL; transformed DLBCL (tDLBCL), including Richter's transformation; follicular lymphoma Grade 3B (FL3B); and primary mediastinal B-cell lymphoma (PMBCL). The study will include subjects who have had prior CD19-directed CAR T-cell exposure and subjects who are CAR T cell-naive. Clinical unmet need exists in both populations.
The objective of this study is to determine the MTD/MAD and following study of UB-VV400 administered alone and in combination with rapamycin. The dose-finding (DF) portion will evaluate the safety profile of UB-VV400 administered at various dose levels (DLs) alone (Stage 1) and in combination with rapamycin (Stage 2).
The dose-expansion (DE) portion will further optimize the dose and define the safety profile and preliminary efficacy of UB-VV400 alone and/or in combination with rapamycin. The study will use the Bayesian optimal interval (BOIN) design to allocate subjects to various DLs to minimize exposure to subtherapeutic DLs while maintaining appropriate safety parameters. DF will consist of 2 stages: Stage 1 DF aims to identify the MTD of UB-VV400 monotherapy, and Stage 2 DF aims to identify the MTD of UB-VV400 in combination with rapamycin. DF will be initiated in Stage 1 with UB-VV400 monotherapy, administered IV and starting at DL1.

Start Date11 Apr 2025

Sponsor / Collaborator

Nanjing IASO Biotherapeutics Co., Ltd.

[+1]

100 Clinical Results associated with UB-VV400

100 Translational Medicine associated with UB-VV400

100 Patents (Medical) associated with UB-VV400

Literatures (Medical) associated with UB-VV400

01 Oct 2026·MOLECULAR THERAPY

In vivo engineering of T cells with a synthetic cytokine receptor enables selective enrichment and expansion of anti-CD22 CAR T cells

Article

Author: Beitz, Laurie O ; Freeman, Jessica ; Friesen, Travis J ; Shin, Seungjin ; Gervascio, Timothy ; Sullivan, Alessandra M ; Ericson, Nolan G ; Larson, Ryan P ; O'Hara, Samantha D ; Perdue, Nikole ; Nicolai, Christopher J ; Teoh, Jeffrey J ; Jarrell, Dillon ; Brandes, Alissa H ; Sheih, Alyssa ; Yingst, Ashley M

Ex vivo-manufactured chimeric antigen receptor (CAR) T cells targeting CD19 have transformed treatment strategies for patients with B cell malignancies and have shown promising results in autoimmune disease. Yet despite their success, significant barriers remain that impede patient access to these therapies, including their complex manufacturing and the need for lymphodepleting chemotherapy. Moreover, many patients who receive ex vivo-manufactured CD19 CAR T cells do not achieve durable responses, suggesting that the expansion and persistence of CAR T cells may need improvement, and/or that strategies targeting alternative antigens may be needed for patients who are refractory to or relapse following treatment with CD19-directed therapies. Umoja is developing a surface-engineered lentiviral vector platform capable of generating CAR T cells in vivo without lymphodepletion. UB-VV400 delivers a payload composed of a fully human anti-CD22 CAR and the rapamycin-activated cytokine receptor (RACR), which enable preferential expansion and enrichment of CAR T cells in response to rapamycin. Here, we describe preclinical studies demonstrating that UB-VV400 generates anti-CD22 CAR T cells that kill CD22-expressing B cells and tumor cells in vitro and in vivo, and that engagement of RACR results in the selective expansion and enrichment of CAR T cells in vivo leading to complete tumor clearance and B cell depletion.

News (Medical) associated with UB-VV400

04 Nov 2026

·www.globenewswire.com

Umoja Biopharma Announces Oral Presentation of First UB-VV400 In Vivo CAR T Cell Therapy Clinical Data and Four Total Presentations at the 68th ASH Annual Meeting

Presentations span UB-VV400 and UB-VV410 clinical data from investigator-initiated trials and trial-in-progress posters for UB-VV400 and UB-VV500SEATTLE, Nov. 04, 2026 (GLOBE NEWSWIRE) -- Umoja Biopharma, Inc. (Umoja), a clinical-stage biotechnology company committed to delivering innovative and potentially curative immunotherapies for patients with cancer and autoimmune diseases, today announced that four abstracts have been accepted for presentation at the 68th American Society of Hematology (ASH) Annual Meeting and Exposition, to be held December 12–15, 2026, at the Ernest N. Morial Convention Center in New Orleans, Louisiana, and virtually. The accepted abstracts include an oral presentation of clinical data from the investigator-initiated trial of UB-VV400, Umoja’s in vivo CD22-directed CAR T cell therapy candidate for relapsed/refractory (R/R) B-cell malignancies, and a poster presentation of clinical data for UB-VV410, an in vivo CD22-directed CAR T cell therapy candidate for systemic lupus erythematosus (SLE) and lupus nephritis (LN). Umoja will also present trial-in-progress posters for the Phase 1/2 study of UB-VV400 and the Phase 1 study of UB-VV500, an in vivo BCMA x GPRC5D-directed CAR T cell therapy candidate for multiple myeloma. Details of the Umoja presentations at ASH 2026 are below. Oral Presentation Title: A phase 1, open-label study of UB-VV400 +/- rapamycin in relapsed or refractory (R/R) B-cell malignanciesDate/Time: Sunday, December 13, 2026, 5:30–5:45 p.m. CTLocation: Ernest N. Morial Convention Center, New Orleans Theatre BPublication Number: 707 Poster Presentation Title: In vivo CAR T-cell generation and B-cell depletion following UB-VV410 administration in patients with treatment-refractory, active systemic lupus erythematosus (SLE)/lupus nephritis (LN)Date/Time: Sunday, December 13, 2026, 6:00–8:00 p.m. CTLocation: Ernest N. Morial Convention Center, Hall FPublication Number: 4174 Poster Presentation (Trial in Progress) Title: A phase 1/2, open-label, multicenter study of UB-VV400 with rapamycin in relapsed or refractory (R/R) B-cell malignanciesDate/Time: Saturday, December 12, 2026, 5:30–7:30 p.m. CTLocation: Ernest N. Morial Convention Center, Hall FPublication Number: 2393 Poster Presentation (Trial in Progress) Title: A phase 1, open-label, multicenter study of UB-VV500 with rapamycin in relapsed or refractory (R/R) multiple myeloma (MM)Date/Time: Sunday, December 13, 2026, 6:00–8:00 p.m. CTLocation: Ernest N. Morial Convention Center, Hall FPublication Number: 4168 About Umoja Biopharma Umoja Biopharma, Inc. is a clinical-stage biotechnology company committed to delivering innovative and potentially curative immunotherapies for patients with cancer and autoimmune diseases. Umoja’s VivoVec™ in vivo gene delivery technology empowers a patient’s own immune system to fight disease. Enabling its core technology is the Company’s state-of-the-art lentiviral vector development and manufacturing facility in Louisville, Colorado. Umoja believes its approach can provide broader access and improved effectiveness of the most advanced immunotherapies, enabling more patients to live better, fuller lives. To learn more, connect with Umoja on LinkedIn and visit umoja-biopharma.com. Contacts: InvestorsNate HardyChief Financial Officerinvestor.relations@umoja-biopharma.com MediaReal Chemistrymedia@umoja-biopharma.com

ImmunotherapyPhase 1Cell TherapyASHGene Therapy

28 Jul 2026

·www.biospace.com

Umoja Biopharma Announces FDA Clearance of IND Application for UB-VV400, the Industry’s First Known CD22-Directed In Vivo CAR T Cell Therapy for Relapsed/Refractory B Cell Malignancies

The company’s lead internal program expands its in vivo CAR T clinical pipeline for patients with relapsed/refractory B cell malignancies First patient expected to be dosed in Q3 2026 SEATTLE, July 16, 2026 (GLOBE NEWSWIRE) -- Umoja Biopharma, Inc., a clinical-stage biotechnology company committed to delivering innovative and potentially curative immunotherapies for patients with cancer and autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) recently cleared its Investigational New Drug (IND) application for UB-VV400, a CD22-directed in vivo CAR T cell therapy candidate for adults with relapsed/refractory B cell malignancies. “UB-VV400 is our second VivoVec™ based in vivo CAR T cell program to advance to U.S. clinical trials,” said Luke Walker, M.D., Chief Medical Officer of Umoja Biopharma. “Generating CAR T cells within a patient’s body would have the potential to transform clinical practice. We designed this Phase 1/2 trial to address a critical, real-world unmet need for patients, including those who have progressed after prior CAR T cell treatment. We remain highly encouraged by the early clinical activity and safety pro in the patients treated in our investigator-initiated trial of UB-VV400, and we look forward to sharing initial clinical data.” The Phase 1/2 VIBRANT-1 study of UB-VV400 will open soon at U.S. clinical sites, with the first patient anticipated to be dosed in Q3 this year. The open-label, dose escalation and expansion trial is designed to evaluate safety and tolerability, pharmacokinetics and pharmacodynamics, and preliminary antitumor activity of UB-VV400 in combination with rapamycin in patients with relapsed/refractory B cell malignancies. Initial clinical data from the investigator-initiated trial of UB-VV400 in China is expected to be shared at a major medical meeting in the second half of 2026. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); About Umoja Biopharma Umoja Biopharma, Inc. is a clinical-stage biotechnology company committed to delivering innovative and potentially curative immunotherapies for patients with cancer and autoimmune diseases. Umoja’s VivoVec™ in vivo gene delivery technology empowers a patient’s own immune system to fight disease. Enabling its core technology is the Company’s state-of-the-art lentiviral vector development and manufacturing facility in Louisville, Colorado. Umoja believes its approach can provide broader access and improved effectiveness of the most advanced immunotherapies, enabling more patients to live better, fuller lives. To learn more, connect with Umoja on LinkedIn and visit umoja-biopharma.com . Contacts: Investors Nate Hardy Chief Financial Officer nate.hardy@umoja-biopharma.com Media Matt Wright Real Chemistry media@umoja-biopharma.com

ImmunotherapyINDClinical StudyCell TherapyGene Therapy

28 Apr 2026

·www.biospace.com

Umoja Biopharma Announces Unveiling of UB-VV500 in Upcoming Poster Presentation at the American Society of Gene & Cell Therapy Annual Meeting

- Industry’s First Combination BCMA x GPRC5D In Vivo CAR T Cell Therapy for the Treatment of Multiple Myeloma - SEATTLE, April 27, 2026 (GLOBE NEWSWIRE) -- Umoja Biopharma, Inc. (Umoja), a clinical-stage biotechnology company committed to delivering innovative and potentially curative immunotherapies for patients with cancer and autoimmune diseases, today announced the acceptance of a poster presentation for UB-VV500, its dual-targeted BCMA x GPRC5D in vivo CAR T cell program for the treatment of multiple myeloma, at the upcoming American Society of Gene & Cell Therapy (ASGCT) Annual Meeting. Preclinical data for UB-VV500 will be presented in a scientific poster at the conference. “Development in multiple myeloma is moving beyond single-targeted approaches toward dual-targeting and combination strategies, particularly as patients progress through existing BCMA-directed therapies,” said Andrew Scharenberg, M.D., co-founder and Chief Executive Officer of Umoja Biopharma. “We believe the future of multiple myeloma immunotherapy will be shaped by combination products that are designed from the ground-up to more effectively address antigen escape and disease heterogeneity while aiming to deliver greater and more durable efficacy. UB-VV500 is designed to realize that vision through our in vivo CAR T cell approach.” Umoja expects to advance UB-VV500 into a Phase 1 clinical trial by the end of 2026. Initial clinical data disclosures across the company’s other clinical programs are expected to be reported at major medical meetings in the second half of 2026. “We are encouraged by our safety and early clinical results in our three ongoing Phase 1 programs—UB-VV111 for CD19 and UB-VV400/UB-VV410 for CD22—which use the same VivoVec TM in vivo platform that UB-VV500 is built upon,” Dr. Scharenberg added. “UB-VV500’s pre-clinical progress is exciting and we look forward to sharing more at ASGCT. Dual-targeting is the future of patient care for multiple myeloma, and we expect UB-VV500 to be at the forefront of that movement.” Details of the ASGCT poster presentation can be found below: Poster Presentation Title: Preclinical development of UB-VV500, an in vivo potency-enhanced CAR T cell product targeting BCMA and GPRC5D for multiple myeloma Presentation Date/Time: Wednesday, May 13, 2026, 5:00 – 6:30 p.m. ET Presenting Speaker: Christopher Nicolai, Ph.D. Publication Number: 2046 About Umoja Biopharma Umoja Biopharma, Inc. is a clinical-stage biotechnology company committed to delivering innovative and potentially curative immunotherapies for patients with cancer and autoimmune diseases. Umoja’s VivoVec™ in vivo gene delivery technology empowers a patient’s own immune system to fight disease. Enabling its core technology is the Company’s state-of-the-art lentiviral vector development and manufacturing facility in Louisville, Colorado. Umoja believes its approach can provide broader access and improved effectiveness of the most advanced immunotherapies, enabling more patients to live better, fuller lives. To learn more, connect with Umoja on LinkedIn and visit umoja-biopharma.com. Investors Nate Hardy Chief Financial Officer nate.hardy@umoja-biopharma.com Media Matt Wright Real Chemistry mwright@realchemistry.com

ImmunotherapyCell Therapy

100 Deals associated with UB-VV400

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Diffuse Large B-Cell Lymphoma	Phase 2	United States	Umoja Biopharma, Inc.	01 Nov 2026
Follicular Lymphoma	Phase 2	United States	Umoja Biopharma, Inc.	01 Nov 2026
High grade B-cell lymphoma	Phase 2	United States	Umoja Biopharma, Inc.	01 Nov 2026
Mediastinal large B-cell lymphoma	Phase 2	United States	Umoja Biopharma, Inc.	01 Nov 2026
Large B-cell lymphoma	Phase 1	China	Nanjing IASO Biotherapeutics Co., Ltd.	11 Apr 2025
B-Cell Malignant Neoplasm	IND Approval	United States	Umoja Biopharma, Inc.	16 Jul 2026
Autoimmune Diseases	Preclinical	United States	Umoja Biopharma, Inc.	13 May 2025

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