UB-VV400 with rapamycin in relapsed/refractory B-cell lymphomas
Official title: A Phase 1/2, Open-label, Multicenter Study of UB-VV400 With Rapamycin in Relapsed or Refractory B-cell Malignancies
Run by Umoja Biopharma · NCT07735533 · Data updated 2026-11-12
A phase 1/2 trial tests UB-VV400 plus rapamycin in adults with relapsed or refractory B-cell lymphomas to see if it is safe and shows anti-tumor activity.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 274 (estimated) |
| Sponsor | Umoja Biopharma Industry-sponsored |
| Drugs / interventions | CAR T |
| Locations | 2 sites (Irvine, California and 1 other locations) |
| Status | Recruiting |
| Started | November 2026 |
| Main results expected | August 2031 |
| Study ends | August 2031 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT07735533 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with relapsed or refractory LBCL or other CD22-expressing B-cell lymphomas and measurable disease.
✕Probably not a fit
Patients with disease not driven by CD22, significant comorbidities, or those who do not respond to the treatment could see no benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a combined phase 1/2 dose-finding and dose-confirmation study enrolling adults with relapsed or refractory B-cell malignancies, including LBCL. Participants will receive UB-VV400 with rapamycin to assess safety and preliminary effectiveness, with responses monitored using standard imaging and disease criteria. The study includes patients whose tumors express CD22 and meet criteria for measurable disease and adequate organ function. Exclusion criteria cover pregnancy, active infections, certain prior therapies, and significant CNS involvement. The trial is led by Umoja Biopharma with sites at City of Hope (CA) and Sarah Cannon Research Institute (TN).
Why it matters
Potential benefit: If successful, participants may experience tumor shrinkage or disease control and gain access to a novel targeted therapy.
How similar studies have gone: Early-phase studies of targeted B-cell therapies have shown activity in similar settings, but this approach is being tested in this specific combination and patient population.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
City of Hope
Irvine, California, United States Recruiting -
Sarah Cannon Research Institute
Nashville, Tennessee, United States Recruiting
Study contacts
- Study coordinator: Luke Walker, MD
- Email: luke.walker@umoja-biopharma.com
- Phone: 206-227-5056
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.