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Related trials:

THINK, NCT03018405; SHRINK, NCT03310008; LINK, NCT03370198.

-Unresectable metastases not treatable by surgical resection or local ablation with curative intent at time of study entry.
– Measurable disease
– The patient is due to receive *first-line metastatic chemotherapy regimen with FOLFOX*, as permitted in this protocol.
– Patients who have received adjuvant chemotherapy or chemoradiotherapy to the pelvis, provided the last dose of chemotherapy was administered at least 6 months prior to the first CYAD-101 administration, are permitted.
THINK – Therapeutic Immunotherapy with CAR-T NKG2D
SHRINK – Standard CHemotherapy Regimen and Immunotherapy with CAR-T NKG2D
LINK – Locoregional Immunotherapy with NKG2D

– THINK is just the NKR-2 cells for many cancer indications, colorectal cancer included; metastasis can be in any place of the body; a dose escalation trial.
LINK and SHRINK are for colorectal liver metastasis: .
– SHRINK combines NKR-2 cells with Folfox to achieve resectability –so it is only for patients with potentially resectable liver mets. .
-LINK is NKR-2 –but only for patients with unresectable liver mets.

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Inclusion Criteria

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

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.