alloSHRINK - Standard cHemotherapy Regimen and Immunotherapy With Allogeneic NKG2D-based CYAD-101 Chimeric Antigen Receptor T-cells

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

Inclusion criteria

• Histologically proven metastatic adenocarcinoma of the colon or rectum.

• Confirmed metastatic unresectable adenocarcinoma of the colon or the rectum.
• Recurrent/progressing disease after at least one line of systemic therapy for metastatic disease.
• Unequivocal and measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
• FOLFOX segment: Neurotoxicity less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 from previous chemotherapy.
• 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.
• 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

• The patient has a confirmed or history of tumor involvement in the central nervous system (CNS).
• Any non-cancer-directed investigational agent within 3 weeks before the planned day for the first CYAD-101 administration.
• Filgrastim (Granulocyte-Colony-Stimulating Factor [G-CSF]) or similar growth factors within 7 days before the planned day for the first CYAD-101 administration.
• Prior allogeneic stem cell transplantation, chimeric antigen receptor therapy or other genetically modified T-cell therapy.