alloSHRINK - Standard cHemotherapy Regimen and Immunotherapy With Allogeneic NKG2D-based CYAD-101 Chimeric Antigen Receptor T-cells
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCelyad Oncology SA
About this trial
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
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
CYAD-101
DrugAllogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells
FOLFOX
Drug5-FU, leucovorin and oxaliplatin
FOLFIRI
Drug5-FU, leucovorin and irinotecan
Treatment groups
49 Participants
are divided into 2 treatment groupsGroup A: CYAD-101 with FOLFOXExperimental treatment 2 interventions
Group B: CYAD-101 with FOLFIRIExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Occurence of Dose Limiting Toxicities
Time frame
Up to 82 days post first CYAD-101 InfusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov