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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Umoja Biopharma
Study ID
NCT07735533
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Diffuse Large B Cell Lymphoma (DLBCL)
  • Grade 3b Follicular Lymphoma
  • High Grade B Cell Lymphoma
  • Lymphoma Non-Hodgkin
  • Lymphoma, B Cell
  • Primary Mediastinal B Cell Lymphoma
  • Richter Transformation Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • UB-VV400 — GENETIC
    UB-VV400 is a gene therapy that generates CD22-directed CAR T cells in the body.
  • Rapamycin (sirolimus) — DRUG
    Rapamycin is a drug approved by the FDA for indications unrelated to cancer.

Study Details

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).

Key Dates

First listed
Jul 30, 2026
Start date
Sep 30, 2026
Status verified
Oct 2026
Primary completion
Aug 31, 2031
Completion
Aug 31, 2031

Study Design

Enrollment
274 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: UB-VV400 + rapamycin
    A single dose of UB-VV400 will be administered followed by treatment with rapamycin.

Primary Outcome Measure

Phase 1: Percentage of participants with common adverse events (AEs) [ Time Frame: Up to 2 years after UB-VV400 administration ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sarah Cannon Research InstituteNashvilleTennessee37203
Clemence Walker
[email protected]
Krish Patel, MD (PRINCIPAL_INVESTIGATOR)

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Sarah Cannon Research Institute· Nashville, TN

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