alloSHRINK - Standard cHemotherapy Regimen and Immunotherapy With Allogeneic NKG2D-based CYAD-101 Chimeric Antigen Receptor T-cells
About this 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
- Condition
- Unresectable Metastatic Colorectal Cancer
- Tested
- CYAD-101, FOLFOX, FOLFIRI
- Sponsor
- Celyad Oncology SA
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 12
- Minimum age: 18 years
- Study condition: Unresectable Metastatic Colorectal Cancer
- Histologically proven metastatic adenocarcinoma of the colon or rectum.
- Confirmed metastatic unresectable adenocarcinoma of the colon or the rectum.
- Recurrent/progressing disease after at least one line of systemic therapy for metastatic disease.
- Unequivocal and measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
- FOLFOX segment: Neurotoxicity less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 from previous chemotherapy.
- 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.
- The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- The patient must have adequate bone marrow reserve, hepatic, renal, pulmonary and cardiac functions.
Exclusion 4
- The patient has a confirmed or history of tumor involvement in the central nervous system (CNS).
- Any non-cancer-directed investigational agent within 3 weeks before the planned day for the first CYAD-101 administration.
- Filgrastim (Granulocyte-Colony-Stimulating Factor \[G-CSF\]) or similar growth factors within 7 days before the planned day for the first CYAD-101 administration.
- Prior allogeneic stem cell transplantation, chimeric antigen receptor therapy or other genetically modified T-cell therapy.
Where
4 sites, 4 recruiting
Institut Jules Bordet
Brussels, Belgium
UZ Antwerpen
Edegem, Belgium
UZ Leuven
Leuven, Belgium
Moffit Cancer Center
Tampa, Florida, United States
Contact
-
Celyad Oncology Medical Monitor, MD, PhD
+3210394100 clinicaltrials@celyad.com
Potential match only. Final eligibility is determined by the study team.