A Phase 1/2 Study of UB-VV400 With Rapamycin in Relapsed/Refractory B-cell Malignancies
NCT07735533 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 274
Last updated 2026-08-17
Summary
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).
Conditions
- Lymphoma, B Cell
- Lymphoma Non-Hodgkin
- High Grade B Cell Lymphoma
- Richter Transformation Lymphoma
- Grade 3b Follicular Lymphoma
- Primary Mediastinal B Cell Lymphoma
- Diffuse Large B Cell Lymphoma (DLBCL)
Interventions
- GENETIC
-
UB-VV400
UB-VV400 is a gene therapy that generates CD22-directed CAR T cells in the body.
- DRUG
-
Rapamycin (sirolimus)
Rapamycin is a drug approved by the FDA for indications unrelated to cancer.
Sponsors & Collaborators
-
Umoja Biopharma
lead INDUSTRY
Principal Investigators
-
Luke Walker, MD · Umoja Biopharma
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-31
- Primary Completion
- 2031-08-31
- Completion
- 2031-08-31
- FDA Drug
- Yes
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