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

Sponsor: Umoja Biopharma

Sponsor score: 0

ClinicalTrials ID:NCT07735533

This Phase 1/2 study assesses UB-VV400's safety and antitumor activity in patients with relapsed/refractory B-cell malignancies. Eligible participants are 18+, with relapsed/refractory LBCL, measurable disease, confirmed CD22 expression, and adequate organ function. Interventions include UB-VV400, a CD22-directed CAR T cell gene therapy, and Rapamycin.

Patient Parameters

Program Overview

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 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.

Locations

FACILITYZIPCITYSTATE
Sarah Cannon Research Institute37203NashvilleTennessee

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