NCT03692429 alloSHRINK - Standard cHemotherapy Regimen and Immunotherapy With Allogeneic NKG2D-based CYAD-101 Chimeric Antigen Receptor T-cells
| NCT ID | NCT03692429 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Celyad Oncology SA |
| Condition | Unresectable Metastatic Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 49 participants |
| Start Date | 2018-11-28 |
| Primary Completion | 2021-11-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 49 participants in total. It began in 2018-11-28 with a primary completion date of 2021-11-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03692429 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Unresectable Metastatic Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03692429 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03692429 currently recruiting?
Yes, NCT03692429 is actively recruiting participants. Contact the research team at clinicaltrials@celyad.com for enrollment information.
Where is the NCT03692429 trial being conducted?
This trial is being conducted at Tampa, United States, Brussels, Belgium, Edegem, Belgium, Leuven, Belgium.
Who is sponsoring the NCT03692429 clinical trial?
NCT03692429 is sponsored by Celyad Oncology SA. The trial plans to enroll 49 participants.
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