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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
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This is an open-label phase I study to determine the safety and recommended phase 2 dose (RP2D) of Senza5 CART5 cells in patients with relapsed or refractory CD5 positive nodal T cell NHL. RP2D will be based on the safety, tolerability, pharmacokinetics, and preliminary efficacy of Senza5 CART5 cells. This trial will evaluate up to 5 dose levels using the Bayesian Optimal Interval (BOIN) design enrolling 3 patients in each cohort to assess safety and achieve therapeutic levels so that the RP2D of Senza5 CART5 cells given as a single IV infusion can be determined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Senza5 CART5 with standard of care lymphodepletion | Experimental | Four treatment arms with Standard of Care Lymphodepletion: Fludarabine 25mg/m2 IV for 3 days Cyclophosphamide 250mg/m2 IV for 3 days |
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| Senza5 CART5 without standard of care lymphodepletion | Experimental | Four treatment arms in patients are lymphopenic into the corresponding dose level. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Senza5 CART5 | Drug | The Senza5 CART5 drug product consists of a dual population of engineered autologous T cells: CD5 knockout (KO)cells and CD5KO-CART5 cells |
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| Measure | Description | Time Frame |
|---|---|---|
| Determine the recommended phase 2 dose (RP2D) of Senza5 CART5 cells | Measure the occurrence of Dose Limiting Toxicity events of each dose level per arm | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the safety of Senza5 CART5 cells | Quantify quantifying the type and frequency of adverse events | 12 months |
| Determine the maximum tolerated dose (MTD) | Quantify the safety and tolerability of the highest dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vittoria Biotherapeutics | Contact | (215) 600-1380 | ClinOps@vittoriabio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | Recruiting | New York | New York | 10032 | United States |
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| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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Open label
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| 12 months |
| Determine the manufacturing feasibility of Senza5 CART5 | Quantify the number of product release failures and occurrence of dose failures (inability to meet targeted dose) | 12 months |
| Determine efficacy of Senza5 CART5 | Measure the objective response rate | 12 months |
| Determine efficacy of Senza5 CART5 | Measure the complete response rate | 12 months |
| Determine efficacy of Senza5 CART5 | Measure the best overall response | 12 months |
| Determine efficacy of Senza5 CART5 | Measure the duration of response | 12 months |
| Determine efficacy of Senza5 CART5 | Measure the overall survival | 12 months |
| Determine efficacy of Senza5 CART5 | Measure the progression free survival | 12 months |
| University of Pennsylvania - Abramson Caner Center | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |