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

July 25, 2024 updated by: Precision BioSciences, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner MDA
    • California
      • Duarte, California, United States, 91010
        • City of Hope
    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
    • New York
      • New York, New York, United States, 10032
        • Columbia University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Lifespan Cancer Institute at Rhode Island Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Level 1

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.
Genetic: PBCAR19B
Single dose of Allogeneic Anti-CD19 CAR T cells will be injected/infused
Other Names:
  • Allogeneic Anti-CD19 CAR T cells
Experimental: Dose Level 2

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.
Genetic: PBCAR19B
Single dose of Allogeneic Anti-CD19 CAR T cells will be injected/infused
Other Names:
  • Allogeneic Anti-CD19 CAR T cells
Experimental: Dose Level 3

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Precision BioSciences, Inc.

Investigators

  • Study Chair: Monika Vainorius, MD, Precision BioSciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2021

Primary Completion (Actual)

December 22, 2022

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

November 24, 2020

First Submitted That Met QC Criteria

November 24, 2020

First Posted (Actual)

December 2, 2020

Study Record Updates

Last Update Posted (Actual)

July 26, 2024

Last Update Submitted That Met QC Criteria

July 25, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBCAR19B-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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