Dose-escalation Study of Safety of PBCAR19B in Participants With CD19-expressing Malignancies

Precision BioSciences

Status and phase: Completed; Phase 1

Conditions: Hematologic Malignancy; CD19 Expressing Malignancies

Treatments: Genetic: PBCAR19B

Study type: Interventional

Funder types: Industry

Identifiers

NCT04649112

PBCAR19B-01

Details and patient eligibility

About

This is a Phase 1, nonrandomized, open-label, single-dose, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of PBCAR19B in adult study participants with CD-19 expressing malignancies.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Relapsed or refractory CD19+ expressing malignancies
• At least 2 prior regimens per Standard of Care

Exclusion criteria

• No history of active CNS involvement

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

13 participants in 3 patient groups

Dose Level 1

Experimental group

Description:

In this study, PBCAR19B, allogeneic anti-CD19 CAR T Cells, is used to treat participants with relapsed or refractory (r/r) Non-Hodgkin Lymphoma (NHL). Route of Administration: Intravenous injection/infusion.

Treatment:

Genetic: PBCAR19B

Dose Level 2

Experimental group

Description:

In this study, PBCAR19B, allogeneic anti-CD19 CAR T Cells, is used to treat participants with relapsed or refractory (r/r) Non-Hodgkin Lymphoma (NHL). Route of Administration: Intravenous injection/infusion.

Treatment:

Genetic: PBCAR19B

Dose Level 3

Experimental group

Description:

In this study, PBCAR19B, allogeneic anti-CD19 CAR T Cells, is used to treat participants with relapsed or refractory (r/r) Non-Hodgkin Lymphoma (NHL). Route of Administration: Intravenous injection/infusion.

Treatment:

Genetic: PBCAR19B