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

Phase 1

Completed

• Conditions: Hematologic Malignancy; CD19 Expressing Malignancies

• Registration Number: NCT04649112
• Lead Sponsor: Precision BioSciences, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-24
• Study First Submitted QC: 2020-11-24
• Study First Posted: 2020-12-02
• Study Start: 2021-06-16
• Primary Completion: 2022-12-22
• Study Completion: 2023-09-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Number of participants with Dose Limiting Toxicity(ies)	1 year	To assess adverse events as dose limiting toxicities as defined by the protocol and CTCAE v5.0.
Maximum Tolerated Dose (MTD)	Day 1 - Day 28	To determine the maximum tolerated dose (MTD)

Trial Locations

Locations (7)

Banner MDA; 🇺🇸 Gilbert, Arizona, United States

City of Hope; 🇺🇸 Duarte, California, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

Columbia University; 🇺🇸 New York, New York, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States

Lifespan Cancer Institute at Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States