For Healthcare Professionals

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

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About the study

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
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Histologically proven metastatic adenocarcinoma of the colon or rectum.
  2. Confirmed metastatic unresectable adenocarcinoma of the colon or the rectum.
  3. Recurrent/progressing disease after at least one line of systemic therapy for metastatic disease.
  4. Unequivocal and measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
  5. FOLFOX segment: Neurotoxicity less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 from previous chemotherapy.
  6. 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.
  7. The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  8. 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.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall +3210394100Email iconEmail Study Center

Study’s details


Contition

Colorectal Cancer,Unresectable Metastatic Colorectal Cancer

Age (in years)

18 - 200

Phase

Phase 1

Participants needed

49

Est. Completion Date

Feb 2036

Treatment type

Interventional


Sponsor

Celyad Oncology SA

ClinicalTrials.gov identifier

NCT03692429

Study number

CYAD-N2L-101

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