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

Celyad Oncology

Status and phase: Enrolling; Phase 1

Conditions: Unresectable Metastatic Colorectal Cancer

Treatments: Drug: FOLFIRI; Drug: FOLFOX; Drug: CYAD-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT03692429

CYAD-N2L-101

Details and patient eligibility

About

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

Full 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

Enrollment: 49 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically proven metastatic adenocarcinoma of the colon or rectum.

   1. Confirmed metastatic unresectable adenocarcinoma of the colon or the rectum.
   2. Recurrent/progressing disease after at least one line of systemic therapy for metastatic disease.
   3. Unequivocal and measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
   4. FOLFOX segment: Neurotoxicity less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 from previous chemotherapy.
   5. 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.

2. The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

3. The patient must have adequate bone marrow reserve, hepatic, renal, pulmonary and cardiac functions.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

49 participants in 2 patient groups

CYAD-101 with FOLFOX

Experimental group

Description:

Infusion after standard FOLFOX chemotherapy

Treatment:

Drug: FOLFOX

Drug: CYAD-101

CYAD-101 with FOLFIRI

Experimental group

Description:

Infusion after standard FOLFIRI chemotherapy

Treatment:

Drug: FOLFIRI

Drug: CYAD-101