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

Umoja Biopharma

Status and phase: Enrolling; Phase 1

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

Treatments: Genetic: UB-VV111; Drug: rapamycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06528301

UB-VV111-01

Details and patient eligibility

About

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).

Enrollment: 106 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 years or older
2. Provides voluntary written informed consent
3. Relapsed or refractory large B-cell lymphoma (LBCL) or chronic lymphocytic leukemia (CLL)
4. Measurable disease according to Lugano 2014 criteria (LBCL) or iwCLL 2018 (CLL).
5. No serious concomitant diseases or active/uncontrolled infections
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
7. Adequate organ function
8. Patients who have previously received CD19-directed therapy must have biopsy confirming CD19 expression following completion of prior CD19-directed therapy.

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 CAR T-cell therapy in CAR T-exposed subjects)
4. History of or active human immunodeficiency virus (HIV)
5. Active hepatitis B or C
6. Systemic autoimmune or 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

UB-VV111

Experimental group

Description:

A single dose of UB-VV111 will be administered.

Treatment:

Genetic: UB-VV111

UB-VV111 + rapamycin

Experimental group

Description:

A single dose of UB-VV111 will be administered followed by treatment with rapamycin.

Treatment:

Drug: rapamycin

Genetic: UB-VV111