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

Starting soon · Phase 1/Phase 2

Conditions studied: 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)

In brief

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 facts

Study ID

NCT07735533

Run by

Umoja Biopharma

People needed

274

Starts

2026-08-01

Expected to finish

2031-08-01

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years or older
• Provides voluntary written informed consent
• Relapsed or refractory large B-cell lymphoma (LBCL)
• Measurable disease according to Lugano 2014 criteria
• Confirmed CD22 expression
• No serious concomitant diseases or active/uncontrolled infections
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate organ function

You may not qualify if…

• Women who are pregnant or breastfeeding
• Current isolated central nervous system (CNS) involvement
• 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)
• History of or active human immunodeficiency virus (HIV)
• Active or chronic hepatitis B, or active hepatitis C
• Systemic immunodeficiency diseases, except for well-controlled Type I diabetes or thyroid disease
• Ongoing CNS disease that would preclude neurologic assessment
• Uncontrolled angina or other acute heart disease
• Currently receiving treatment in another interventional clinical trial.

Full record on ClinicalTrials.gov

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