NCT04030195

Dose-escalation Study of Safety of PBCAR20A in Subjects With r/r NHL or r/r CLL/SLL

A Phase 1/2a, Open-label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate the Safety and 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)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Precision BioSciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/2a, nonrandomized, open-label, parallel assignment, single-dose, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of PBCAR20A in adult subjects with r/r B-cell NHL or r/r CLL/SLL.

Detailed description

This is a multicenter, nonrandomized, open-label, parallel assignment, single-dose, dose-escalation, and dose-expansion study to evaluate safety, tolerability, clinical activity, and find an appropriate dose to optimize safety and efficacy of PBCAR20A in subjects with relapsed/refractory (r/r) CD20+ Non-Hodgkin Lymphoma (NHL) or r/r Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). Before initiating PBCAR20A, therapy, 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.

Conditions

• Non-Hodgkin's Lymphoma, Relapsed
• Chronic Lymphoid Leukemia in Relapse
• Non-Hodgkin's Lymphoma Refractory
• Chronic Lymphocytic Leukemia
• Lymphoma, Non-Hodgkin
• Leukemia, Lymphocytic, Chronic
• B-cell Chronic Lymphocytic Leukemia
• B-cell Non Hodgkin Lymphoma
• Small Lymphocytic Lymphoma

Interventions

Type	Name	Description
GENETIC	PBCAR20A	Single dose of Allogeneic Anti-CD20 CAR T cells will be infused, and a classic "3+3" dose escalation will be applied.
DRUG	Fludarabine	Fludarabine is used for lymphodepletion (30 mg/m\^2/day, Days -5 to -3).
DRUG	Cyclophosphamide	Cyclophosphamide is used for lymphodepletion (500 mg/m\^2/day, Days -5 to -3).

Timeline

• Start date: 2020-03-24
• Primary completion: 2021-06-24
• Completion: 2021-06-24
• First posted: 2019-07-23
• Last updated: 2023-01-31
• Results posted: 2023-01-31

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study