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

Sponsor
Precision BioSciences, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04649112
Collaborator
(none)
24
5
3
27.5
4.8
0.2

Study Details

Study Description

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
  • Genetic: PBCAR19B
Phase 1

Study Design

Study Type:
Interventional
Anticipated 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 :
Jun 16, 2021
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Maximum Tolerated Dose (MTD) [Day 1 - Day 28]

      To determine the maximum tolerated dose (MTD)

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 City of Hope Duarte California United States 91010
    2 Tufts Medical Center Boston Massachusetts United States 02111
    3 Columbia University New York New York United States 10032
    4 Thomas Jefferson University Philadelphia Pennsylvania United States 19107
    5 Lifespan Cancer Institute at Rhode Island Hospital Providence Rhode Island United States 02903

    Sponsors and Collaborators

    • Precision BioSciences, Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Precision BioSciences, Inc.
    ClinicalTrials.gov Identifier:
    NCT04649112
    Other Study ID Numbers:
    • PBCAR19B-01
    First Posted:
    Dec 2, 2020
    Last Update Posted:
    Mar 2, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 2, 2022