Dose-escalation Study of Safety of PBCAR20A in Subjects With r/r NHL or r/r CLL/SLL
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- B Cell Chronic Lymphocytic Leukemia
- B-cell Non Hodgkin Lymphoma
- Chronic Lymphocytic Leukemia
- Chronic Lymphoid Leukemia in Relapse
- Leukemia, Lymphocytic, Chronic
- Lymphoma Non-Hodgkin
- Non-Hodgkin's Lymphoma Refractory
- Non-Hodgkin's Lymphoma, Relapsed
- Small Lymphocytic Lymphoma
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Part 1: In each cohort, B-cell NHL (Cohort A) or r/r CLL/SLL (Cohort B), 3 escalating dose groups will be enrolled and treated sequentially, with the possibility of a single de-escalation. Within each dose group, at least 3 and at most 6 study participants will be treated with a single dose of PBCAR20A using a standard 3 + 3 design. The starting dose of PBCAR20A will be 3 × 10^5 CAR T cells/kg body weight. Subsequent dose groups will be treated with escalating doses to a maximum dose of 3 × 10^6 CAR T cells/kg. In the absence of DLTs (as described in Section 3.7), the dose will be increased using a fixed-dose scheme. Part 2: Upon the determination of the MTDs for Cohorts A and B, these respective doses will be used in the dose-expansion part, in which additional study participants will be enrolled and treated. Study participants in the expanded cohorts will be treated with a single dose of PBCAR20A.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a multicenter, nonrandomized, open-label, parallel assignment, single-dose, dose-escalation, and dose-expansion study to evaluate the safety and tolerability, find an appropriate dose to optimize safety and efficacy, and evaluate clinical activity of PBCAR20A in subjects with relapsed/refrac...
This is a multicenter, nonrandomized, open-label, parallel assignment, single-dose, dose-escalation, and dose-expansion study to evaluate the safety and tolerability, find an appropriate dose to optimize safety and efficacy, and evaluate clinical activity of PBCAR20A in subjects with relapsed/refractory (r/r) Non-Hodgkin Lymphoma (NHL) or r/r Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). Before initiating PBCAR20A, subjects will be administered lymphodepletion chemotherapy composed of fludarabine and cyclophosphamide. At Day 0 of the Treatment Period, subjects will receive a single intravenous (IV) infusion of PBCAR20A. All subjects are monitored during the treatment period through Day 28. All subjects who receive a dose of PBCAR20A will be followed in a separate long-term follow-up (LTFU) study for 15 years after exiting this study.
Tracking Information
- NCT #
- NCT04030195
- Collaborators
- Not Provided
- Investigators
- Study Chair: Monika Vainorius, MD Precision BioSciences, Inc.
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