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A Phase 1/2 Study of UB-VV400 With Rapamycin in Relapsed/Refractory B-cell Malignancies
RecruitingPhase 1/2
A Phase 1/2, Open-label, Multicenter Study of UB-VV400 With Rapamycin in Relapsed or Refractory B-cell Malignancies
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: 1. 18 years or older 2. Provides voluntary written informed consent 3. Relapsed or refractory large B-cell lymphoma (LBCL) 4. Measurable disease according to Lugano 2014 criteria 5. Confirmed CD22 expression 6. No serious concomitant diseases or active/uncontrolled infections 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 8. Adequate organ function Exclusion Criteria: 1. Women who are pregnant or breastfeeding 2. Current isolated central nervous system (CNS) involvement 3. Prior allogeneic bone marrow transplant, gene therapy, or adoptive cell transfer (except tumor-infiltrating lymphocytes, CAR-NK cells, T-cell receptor \[TCR\] fusion constructs, TCR T cells, and CAR T cells) 4. History of or active human immunodeficiency virus (HIV) 5. Active or chronic hepatitis B, or active hepatitis C 6. Systemic immunodeficiency diseases, except for well-controlled Type I diabetes or thyroid disease 7. Ongoing CNS disease that would preclude neurologic assessment 8. Uncontrolled angina or other acute heart disease 9. Currently receiving treatment in another interventional clinical trial.
About the study
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).
What is being tested
- UB-VV400 (genetic)
- Rapamycin (sirolimus) (drug)
Sponsor: Umoja Biopharma · Participants: 274 · Started: 2026-11
Contact the study team
- Luke Walker, MD · Phone: 206-227-5056
Official record on ClinicalTrials.gov — NCT07735533
Locations in the U.S.
| California | City of Hope, Irvine |
| Tennessee | Sarah Cannon Research Institute, Nashville |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.