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Recruiting Phase 1/2

A Phase 1/2 Study of UB-VV400 With Rapamycin in Relapsed/Refractory B-cell Malignancies

NCT07735533 · tracked via the Priya Life Science USA tracker
Sponsor
Umoja Biopharma
Phase
Phase 1/2
Started
2026-09
Last updated
2026-10-09

Condition(s) studied

Lymphoma, B CellLymphoma Non-HodgkinHigh Grade B Cell LymphomaRichter Transformation LymphomaGrade 3b Follicular LymphomaPrimary Mediastinal B Cell LymphomaDiffuse Large B Cell Lymphoma (DLBCL)

Investigational drug(s) / intervention(s)

UB-VV400Rapamycin (sirolimus) →

UB-VV400: UB-VV400 is a gene therapy that generates CD22-directed CAR T cells in the body.

Rapamycin (sirolimus): Rapamycin is a drug approved by the FDA for indications unrelated to cancer.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Phase 1: Percentage of participants with common adverse events (AEs) — Up to 2 years after UB-VV400 administration
    Percentage of participants with commonly reported AEs overall and by severity
  • Phase 2: Overall response rate (ORR) — Up to 2 years after UB-VV4001 administration
    Percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR)

Trial sites (1)

FacilityCityRegionStatus
Sarah Cannon Research Institute Nashville Tennessee Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07735533 on ClinicalTrials.gov ↗ ← All trials in the USA