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OpenTrials
Completed

NCT Number: NCT04649112

Dose-escalation Study of Safety 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.

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Key information

Conditions

CD19 Expressing Malignancies Hematologic Diseases Hematologic Malignancy Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Banner MDA, Gilbert, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PBCAR19B

Genetic

Single dose of Allogeneic Anti-CD19 CAR T cells will be injected/infused

Other names: Allogeneic Anti-CD19 CAR T cells

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Precision BioSciences, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Dec 2, 2020
Registry last updated
Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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