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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04649112
Recruitment Status : Recruiting
First Posted : December 2, 2020
Last Update Posted : November 9, 2022
Sponsor:
Information provided by (Responsible Party):
Precision BioSciences, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
CD19 Expressing Malignancies Hematologic Malignancy Genetic: PBCAR19B Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of PBCAR19B in Participants With CD19-expressing Malignancies
Actual Study Start Date : June 16, 2021
Estimated Primary Completion Date : December 22, 2022
Estimated Study Completion Date : September 30, 2023
Arms and Interventions
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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 Name: 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 Name: 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 Name: Allogeneic Anti-CD19 CAR T cells


Outcome Measures
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Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) [ Time Frame: Day 1 - Day 28 ]
    To determine the maximum tolerated dose (MTD)

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04649112


Contacts
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Contact: Clinical Precision BioSciences, Inc. 919-314-5512 clinical@precisionbiosciences.com

Locations
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United States, Arizona
Banner MDA Recruiting
Gilbert, Arizona, United States, 85234
Contact: Rajneesh Nath, MD         
Principal Investigator: Rajneesh Nath, MD         
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Alex Herrera, MD         
Principal Investigator: Alex Herrera, MD         
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Michael Jain, MD         
Principal Investigator: Michael Jain, MD         
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Andreas Klein, MD         
Principal Investigator: Andreas Klein, MD         
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Ran Reshef, MD         
Principal Investigator: Ran Reshef, MD         
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Usama Gergis, MD         
Principal Investigator: Usama Gergis, MD         
United States, Rhode Island
Lifespan Cancer Institute at Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Adam Olszewski, MD         
Principal Investigator: Adam Olszewski, MD         
Sponsors and Collaborators
Precision BioSciences, Inc.
Investigators
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Study Chair: Monika Vainorius, MD Precision BioSciences, Inc.
More Information
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Responsible Party: Precision BioSciences, Inc.
ClinicalTrials.gov Identifier: NCT04649112    
Other Study ID Numbers: PBCAR19B-01
First Posted: December 2, 2020    Key Record Dates
Last Update Posted: November 9, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases