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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Level 1 | Experimental | 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. |
|
| Dose Level 2 | Experimental | 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. |
|
| Dose Level 3 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PBCAR19B | Genetic | Single dose of Allogeneic Anti-CD19 CAR T cells will be injected/infused |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Monika Vainorius, MD | Precision BioSciences, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MDA | Gilbert | Arizona | 85234 | United States | ||
| City of Hope |
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| 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 |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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