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Clinical Trials in the USA / NCT03692429
Recruiting Phase 1

alloSHRINK - Standard cHemotherapy Regimen and Immunotherapy With Allogeneic NKG2D-based CYAD-101 Chimeric Antigen Receptor T-cells

NCT03692429 · tracked via the Priya Life Science USA tracker
Sponsor
Celyad Oncology SA
Phase
Phase 1
Started
2018-11-28
Last updated
2020-11-20

Condition(s) studied

Unresectable Metastatic Colorectal Cancer

Investigational drug(s) / intervention(s)

CYAD-101FOLFOXFOLFIRI

CYAD-101: Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells

FOLFOX: 5-FU, leucovorin and oxaliplatin

FOLFIRI: 5-FU, leucovorin and irinotecan

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
Moffit Cancer Center Tampa Florida Not Yet Recruiting
Institut Jules Bordet Brussels Belgium Recruiting
UZ Antwerpen Edegem Belgium Recruiting
UZ Leuven Leuven Belgium Recruiting

More Celyad Oncology SA trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03692429 on ClinicalTrials.gov ↗ ← All trials in the USA