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

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Precision BioSciences, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Dose Level 3 of PBCAR20A CAR T cellsExperimental Treatment3 Interventions

480 x 10\^6 CAR T cells (flat dose)

Group II: Dose Level 2 of PBCAR20A CAR T cellsExperimental Treatment3 Interventions

240 x 10\^6 CAR T cells (flat dose)

Group III: Dose Level 1 of PBCAR20A CAR T cellsExperimental Treatment3 Interventions

1 x 10\^6 chimeric antigen receptor (CAR) T cells per kg body weight. In this study, PBCAR20A, allogeneic anti-cluster of differentiation (CD20) CAR T Cells, is used to treat patients with relapsed or refractory (r/r) CD20+ Non-Hodgkin Lymphoma (NHL) or r/r Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). Route of Administration: Intravenous infusion (IV) Lymphodepletion Conditioning: Lymphodepletion will be conducted several days prior to PBCAR20A infusion. A combination of fludarabine and cyclophosphamide will be used for lymphodepletion.