FDA Lifts Hold on Novel CAR-T Cell Therapy for Colorectal Cancer

The FDA will allow the study of CYAD-101, a novel CAR-T cell therapy, to continue in patients with metastatic colorectal cancer now that the eligibility criteria for the trial has been amended.

The Food and Drug Administration (FDA) lifted its clinical hold on the phase 1b KEYNOTE-B79 clinical trial examining CYAD-101 plus FOLFOX chemotherapy (leucovorin, 5-fluorouracil and oxaliplatin) and then Keytruda (pembrolizumab) in patients with unresectable metastatic colorectal cancer with microsatellite stable/mismatch-repair proficient disease.

Celyad Oncology, the pharmaceutical company developing CYAD-101, originally paused the trial in February 2022 to investigate two deaths that occurred on the trial. Then in March, the FDA put a clinical hold on the trial, meaning that no new patients could be recruited and administered CYAD-101, and those already on the trial should not be administered the drug unless specified by the FDA.

Recently, Celyad made changes to who is eligible to participate in the trial, resulting in the FDA lifting the clinical hold.

Researchers on KEYNOTE-B79 are now enrolling patients with unresectable adenocarcinoma of the colon or rectum who have a confirmed non-microsatellite instability high and mismatch-repair proficient tumors. Patients must have measurable disease, that has progressed after one or more lines of systemic therapy, including FOLFOX, are due to receive FOLFOX and do not have major neurotoxicity from prior chemotherapy.

Eligible participants must also have an ECOG performance status of 0 or 1 (meaning that they are able to perform all or most of their daily tasks independently) and have adequate organ, lung and heart function.

Patients cannot enroll in the trial if: they received another investigational drug or device within four weeks of the first study treatment; received another anticancer drug within four weeks of the first study treatment; are currently taking filgrastim or similar growth factors within seven days of the first study treatment; have previously been treated with an anti—PD-1, PD-L1, or PD-2 drug; undergo radiotherapy within two weeks of the first study treatment; or undergo major surgery within four weeks before the start of the study treatment.

CYAD-101 is a novel CAR-T cell therapy that uses cells from healthy donors, rather than the patients.

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