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The purpose of the alloSHRINK study is to assess the safety, cell kinetics and clinical activity of CYAD-101 in patients with unresectable metastatic colorectal cancer administered after standard chemotherapy
This Study aims to determine and confirm the recommended dose of the allogeneic CYAD-101 cells after standard FOLFOX or FOLFIRI chemotherapy in patients with unresectable metastatic colorectal cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CYAD-101 with FOLFOX | Experimental | Infusion after standard FOLFOX chemotherapy |
|
| CYAD-101 with FOLFIRI | Experimental | Infusion after standard FOLFIRI chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CYAD-101 | Drug | Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurence of Dose Limiting Toxicities | Up to 82 days post first CYAD-101 Infusion |
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Inclusion Criteria:
Histologically proven metastatic adenocarcinoma of the colon or rectum.
The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
The patient must have adequate bone marrow reserve, hepatic, renal, pulmonary and cardiac functions.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Celyad Oncology Medical Monitor, MD, PhD | Contact | +3210394100 | clinicaltrials@celyad.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffit Cancer Center | Not yet recruiting | Tampa | Florida | 33612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35191428 | Derived | Michaux A, Mauen S, Breman E, Dheur MS, Twyffels L, Saerens L, Jacques-Hespel C, Gauthy E, Agaugue S, Gilham DE, Sotiropoulou PA. Clinical Grade Manufacture of CYAD-101, a NKG2D-based, First in Class, Non-Gene-edited Allogeneic CAR T-Cell Therapy. J Immunother. 2022 Apr 1;45(3):150-161. doi: 10.1097/CJI.0000000000000413. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 26, 2022 | |
| Reset | Sep 5, 2023 |
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| FOLFOX | Drug | 5-FU, leucovorin and oxaliplatin |
|
| FOLFIRI | Drug | 5-FU, leucovorin and irinotecan |
|
| Institut Jules Bordet | Recruiting | Brussels | 1000 | Belgium |
|
| UZ Antwerpen | Recruiting | Edegem | 2650 | Belgium |
|
| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
|
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 26, 2022 | Sep 5, 2023 |
| ID | Term |
|---|---|
| C410216 | Folfox protocol |
| C480833 | IFL protocol |
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