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

Phase 2Not Yet RecruitingNCT07735533

Umoja Biopharma274 enrolled

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

274

Conditions

Lymphoma, B Cell Lymphoma Non-Hodgkin High Grade B Cell Lymphoma Richter Transformation Lymphoma Grade 3b Follicular Lymphoma Primary Mediastinal B Cell Lymphoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Phase 1: Percentage of participants with common adverse events (AEs)

Percentage of participants with commonly reported AEs overall and by severity

Time frame: Up to 2 years after UB-VV400 administration

Phase 2: Overall response rate (ORR)

Percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR)

Time frame: Up to 2 years after UB-VV4001 administration

Secondary Outcomes

Phase 1: Overall response rate (ORR)

Percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR)

Time frame: Up to 2 years after UB-VV400 administration

Phase 1 and Phase 2: Complete response rate (CRR)

Percentage of participants with a best overall response (BOR) of complete response (CR)

Time frame: Up to 2 years after UB-VV400 administration

Phase 1 and Phase 2: Pharmacokinetics (PK) of UB-VV400

Maximum concentration (Cmax), time to maximum concentration (Tmax), and AUC (area under the concentration vs time curve) for UB-VV400

Time frame: Up to 8 days after UB-VV400 administration

Phase 2: Percentage of participants with common AEs

Percentage of participants with commonly reported AEs overall and by severity

Time frame: Up to 2 years after UB-VV111 administration

Phase 2: Duration of response (DOR)

Duration from first evidence of response (CR or PR) to date of first evidence of disease progression or death, whichever is earlier

Time frame: Up to 2 years after UB-VV400 administration

Phase 2: Progression-free survival (PFS)

Duration from first administration of UB-VV400 to the first evidence of disease progression or death from any cause, whichever is earlier.

Time frame: Up to 2 years after UB-VV400 administration

Phase 2: Overall survival (OS)

Duration from first administration of UB-VV400 to death from any cause

Time frame: Up to 2 years after UB-VV400 administration

Phase 2: Quality of life (QOL)

Performance on 2 QoL scales: EuroQol instrument EQ-5D-5L and Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)

Time frame: Up to 2 years after UB-VV400 administration

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts