Dose-escalation Study of Safety of PBCAR19B in Participants With CD19-expressing Malignancies
A Phase 1 Study of PBCAR19B in Participants With CD19-expressing Malignancies
1 other identifier
interventional
13
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2021
Typical duration for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2020
CompletedFirst Posted
Study publicly available on registry
December 2, 2020
CompletedStudy Start
First participant enrolled
June 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedJuly 26, 2024
July 1, 2024
1.5 years
November 24, 2020
July 25, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Maximum Tolerated Dose (MTD)
To determine the maximum tolerated dose (MTD)
Day 1 - Day 28
Number of participants with Dose Limiting Toxicity(ies)
To assess adverse events as dose limiting toxicities as defined by the protocol and CTCAE v5.0.
1 year
Study Arms (3)
Dose Level 1
EXPERIMENTALIn 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 2
EXPERIMENTALIn 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 3
EXPERIMENTALIn 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.
Interventions
Single dose of Allogeneic Anti-CD19 CAR T cells will be injected/infused
Eligibility Criteria
You may qualify if:
- Relapsed or refractory CD19+ expressing malignancies
- At least 2 prior regimens per Standard of Care
You may not qualify if:
- No history of active CNS involvement
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Banner MDA
Gilbert, Arizona, 85234, United States
City of Hope
Duarte, California, 91010, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Columbia University
New York, New York, 10032, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Lifespan Cancer Institute at Rhode Island Hospital
Providence, Rhode Island, 02903, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Monika Vainorius, MD
Precision BioSciences, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2020
First Posted
December 2, 2020
Study Start
June 16, 2021
Primary Completion
December 22, 2022
Study Completion
September 30, 2023
Last Updated
July 26, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share