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NCT04649112 Clinical Trial

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

Hematologic Malignancy Clinical Trial

Official title:
A Phase 1 Study of PBCAR19B in Participants With CD19-expressing Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04649112
Other study ID # PBCAR19B-01
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date June 16, 2021
Est. completion date September 30, 2023

Study information
Verified date November 2022
Source Precision BioSciences, Inc.
Contact Clinical Precision BioSciences, Inc.
Phone 919-314-5512
Email clinical@precisionbiosciences.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 24
Est. completion date September 30, 2023
Est. primary completion date December 22, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Genetic:
• PBCAR19B
Single dose of Allogeneic Anti-CD19 CAR T cells will be injected/infused

Locations
Country Name City State
United States Tufts Medical Center Boston Massachusetts
United States City of Hope Duarte California
United States Banner MDA Gilbert Arizona
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 Moffitt Cancer Center Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
Precision BioSciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Maximum Tolerated Dose (MTD) To determine the maximum tolerated dose (MTD) Day 1 - Day 28
Primary Number of participants with Dose Limiting Toxicity(ies) To assess adverse events as dose limiting toxicities as defined by the protocol and CTCAE v5.0. 1 year
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