Clinical Trials /

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

NCT04649112

Description:

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.

Related Conditions:
  • Non-Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT04649112

Trial Eligibility

Document

Title

  • Brief Title: Dose-escalation Study of Safety of PBCAR19B in Participants With CD19-expressing Malignancies
  • Official Title: A Phase 1 Study of PBCAR19B in Participants With CD19-expressing Malignancies

Clinical Trial IDs

  • ORG STUDY ID: PBCAR19B-01
  • NCT ID: NCT04649112

Conditions

  • CD19 Expressing Malignancies
  • Hematologic Malignancy

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Dose Level 1ExperimentalIn 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.
    Dose Level 2ExperimentalIn 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.
      Dose Level 3ExperimentalIn 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.

        Eligibility 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
        Maximum Eligible Age:N/A
        Minimum Eligible Age:18 Years
        Eligible Gender:All
        Healthy Volunteers:No

        Primary Outcome Measures

        Measure:Maximum Tolerated Dose (MTD)
        Time Frame:Day 1 - Day 28
        Safety Issue:
        Description:To determine the maximum tolerated dose (MTD)

        Details

        Phase:Phase 1
        Primary Purpose:Interventional
        Overall Status:Recruiting
        Lead Sponsor:Precision BioSciences, Inc.

        Last Updated

        July 2, 2021