Overview

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

Status:
Recruiting

Trial end date:
2036-02-17

Target enrollment:
0

Participant gender:
All

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

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Celyad (formerly named Cardio3 BioSciences)
Celyad Oncology SA

Collaborator:

Novella Clinical

Treatments:

Fluorouracil
Oxaliplatin

Criteria

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.