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A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies

NCT06528301 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2026-01-12

No results posted yet for this study

Summary

This study is a Phase 1 dose-escalation and dose-confirmation study to evaluate the safety and antitumor activity of UB-VV111. The study will enroll patients with relapsed/refractory large B-cell lymphoma (LBCL) and chronic lymphocytic leukemia (CLL).

Conditions

  • Lymphoma, B-Cell
  • Lymphoma, Non-Hodgkin (NHL)
  • Lymphoma, Large B-Cell, Diffuse (DLBCL)
  • Chronic Lymphocytic Leukemia (CLL)

Interventions

GENETIC

UB-VV111

UB-VV111 is a gene therapy that generates CD19 CAR T cells in the body.

DRUG

rapamycin

Rapamycin is an FDA-approved drug.

Sponsors & Collaborators

  • Umoja Biopharma

    lead INDUSTRY

Principal Investigators

  • Jacob Garcia, MD · Umoja Biopharma

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-10
Primary Completion
2029-03-31
Completion
2029-03-31
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Drugs

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 NCT06528301 on ClinicalTrials.gov