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

No results posted yet for this 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).

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

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07735533 on ClinicalTrials.gov