alloSHRINK - Standard cHemotherapy Regimen and Immunotherapy With Allogeneic NKG2D-based CYAD-101 Chimeric Antigen Receptor T-cells
Study Details
Study Description
Brief Summary
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
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Detailed Description
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
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: CYAD-101 with FOLFOX Infusion after standard FOLFOX chemotherapy |
Drug: CYAD-101
Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells
Drug: FOLFOX
5-FU, leucovorin and oxaliplatin
|
Experimental: CYAD-101 with FOLFIRI Infusion after standard FOLFIRI chemotherapy |
Drug: CYAD-101
Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells
Drug: FOLFIRI
5-FU, leucovorin and irinotecan
|
Outcome Measures
Primary Outcome Measures
- Occurence of Dose Limiting Toxicities [Up to 82 days post first CYAD-101 Infusion]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologically proven metastatic adenocarcinoma of the colon or rectum.
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Confirmed metastatic unresectable adenocarcinoma of the colon or the rectum.
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Recurrent/progressing disease after at least one line of systemic therapy for metastatic disease.
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Unequivocal and measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
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FOLFOX segment: Neurotoxicity less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 from previous chemotherapy.
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FOLFIRI segment: Documented progressive disease (PD) under FOLFIRI treatment, with or without targeted therapy, given within 3 months prior to study registration. Anti-cancer therapy post FOLFIRI-documented PD prior to study registration is authorized if discontinued at least 7 days before the planned study registration. Radiotherapy is not authorized.
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The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
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The patient must have adequate bone marrow reserve, hepatic, renal, pulmonary and cardiac functions.
Exclusion Criteria:
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The patient has a confirmed or history of tumor involvement in the central nervous system (CNS).
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Any non-cancer-directed investigational agent within 3 weeks before the planned day for the first CYAD-101 administration.
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Filgrastim (Granulocyte-Colony-Stimulating Factor [G-CSF]) or similar growth factors within 7 days before the planned day for the first CYAD-101 administration.
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Prior allogeneic stem cell transplantation, chimeric antigen receptor therapy or other genetically modified T-cell therapy.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Moffit Cancer Center | Tampa | Florida | United States | 33612 |
2 | Institut Jules Bordet | Brussels | Belgium | 1000 | |
3 | UZ Antwerpen | Edegem | Belgium | 2650 | |
4 | UZ Leuven | Leuven | Belgium | 3000 |
Sponsors and Collaborators
- Celyad Oncology SA
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CYAD-N2L-101