Dose-escalation Study of Safety of PBCAR19B in Participants With CD19-expressing Malignancies
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 |
---|---|---|
|
Phase 1 |
Study Design
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:
|
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:
|
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:
|
Outcome Measures
Primary Outcome Measures
- Maximum Tolerated Dose (MTD) [Day 1 - Day 28]
To determine the maximum tolerated dose (MTD)
- 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
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.- PBCAR19B-01