Dose-escalation Study of Safety of PBCAR0191 in Patients With r/r NHL and r/r B-cell ALL
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 80
Summary
- Conditions
- B-cell Acute Lymphoblastic Leukemia
- Non Hodgkin Lymphoma
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: In each cohort (NHL and B-ALL), up to 6 dose levels will be enrolled and treated sequentially. Within each dose level, up to 6 subjects will be treated with PBCAR0191 using a standard 3 + 3 design. The starting dose of PBCAR0191 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 9 × 10^6 CAR T cells/kg. In the absence of DLTs, the dose will be increased using a fixed dose scheme.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, 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 PBCAR0191 in subjects with relapsed/refractory (r/r) B...
This is a multicenter, nonrandomized, open-label, parallel assignment, 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 PBCAR0191 in subjects with relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL) and non-Hodgkin lymphoma (NHL). Before initiating PBCAR0191, subjects will be administered lymphodepletion chemotherapy composed of fludarabine and cyclophosphamide. At Day 0 of the Treatment Period, subjects will receive an intravenous (IV) infusion of PBCAR0191. Subjects who receive a split dose will also receive an IV infusion of PBCAR0191 on Day 10 and/or Day 14. Subjects may be considered for retreatment. All subjects are monitored during the treatment period through Day 28. All subjects who receive a dose of PBCAR0191 will be followed in a separate long-term follow-up (LTFU) study for 15 years after exiting this study.
Tracking Information
- NCT #
- NCT03666000
- Collaborators
- Not Provided
- Investigators
- Study Chair: Monika Vainorius, MD Precision BioSciences, Inc.
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