Combination of chemotherapy and immunotherapy for advanced colorectal cancer
An Open-label, Phase I Study to Assess the Safety of Multiple Doses of CYAD-101, Administered After Standard FOLFOX or FOLFIRI Chemotherapy in Patients With Unresectable Metastatic Colorectal Cancer
This study is testing if a new immune therapy combined with standard chemotherapy can help people with advanced colorectal cancer feel better and improve their treatment outcomes.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 49 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Celyad Oncology SA Industry-sponsored |
| Drugs / interventions | chimeric antigen receptor, chemotherapy |
| Locations | 4 sites (Tampa, Florida and 3 other locations) |
| Trial ID | NCT03692429 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically confirmed unresectable metastatic adenocarcinoma of the colon or rectum who have experienced disease progression after prior systemic therapy.
Not a fit: Patients with resectable tumors or those who have not received prior systemic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option that enhances the effectiveness of chemotherapy in patients with advanced colorectal cancer.
How similar studies have performed: Other studies combining immunotherapy with chemotherapy have shown promising results, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tampa, Florida and 3 other locations
- Moffit Cancer Center — Tampa, Florida, United States (Not_yet_recruiting)
- Institut Jules Bordet — Brussels, Belgium (Recruiting)
- UZ Antwerpen — Edegem, Belgium (Recruiting)
- UZ Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Study coordinator: Celyad Oncology Medical Monitor, MD, PhD
- Email: clinicaltrials@celyad.com
- Phone: +3210394100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.