Combination of chemotherapy and immunotherapy for advanced colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The alloSHRINK study evaluates the safety and effectiveness of CYAD-101, an allogeneic chimeric antigen receptor T-cell therapy, in patients with unresectable metastatic colorectal cancer. Participants will receive standard chemotherapy regimens, FOLFOX or FOLFIRI, followed by CYAD-101 to assess its clinical activity and cell kinetics. The study aims to determine the optimal dose of CYAD-101 after chemotherapy treatment. This phase 1 trial will help establish the potential of combining immunotherapy with traditional chemotherapy in this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Institut Jules Bordet
  Brussels, Belgium Recruiting
• UZ Antwerpen
  Edegem, Belgium Recruiting
• UZ Leuven
  Leuven, Belgium Recruiting
• Moffit Cancer Center
  Tampa, Florida, United States Not yet recruiting

Study contacts

• Study coordinator: Celyad Oncology Medical Monitor, MD, PhD
• Email: clinicaltrials@celyad.com
• Phone: +3210394100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.