Last updated on November 2019

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


Brief description of study

This open-label Phase I study aims at assessing the safety, cell kinetics and clinical activity of the CYAD-101 treatment administered 3 times with a 2-week interval between each administration in metastatic colorectal cancer, concurrently with a standard chemotherapy treatment. The standard chemotherapy treatment consists in 6 consecutive cycles of FOLFOX, administered with a 2-week interval. The CYAD-101 treatment will be administered at a specific time point within the third, fourth and fifth chemotherapy cycles.

This Phase I study will contain two consecutive segments: a dose-escalation and an expansion

segment

The first segment (dose-escalation segment) will use a 3+3 design to determine the recommended dose of CYAD-101 on the basis of dose-limiting toxicities (DLTs).

The second segment (expansion segment) of the study will evaluate 3 injections of CYAD-101 at the recommended dose defined in the first segment, administered concurrently with FOLFOX, in a larger number of patients.

Detailed Study Description

This open-label Phase I study aims at assessing the safety, cell kinetics and clinical activity of the CYAD-101 treatment administered 3 times with a 2-week interval between each administration in metastatic CRC, concurrently with a standard chemotherapy treatment. The standard chemotherapy treatment consists of 6 consecutive cycles of FOLFOX administered with a 2-week interval. The CYAD-101 treatment will start at Day 3 of the third chemotherapy cycle.

This Phase I study will contain two consecutive segments: a dose-escalation and an expansion

segment

The dose-escalation segment will evaluate the safety of three injections of CYAD-101 administered concurrently with FOLFOX in patients with metastatic CRC. A 3+3 design will be used to determine the recommended dose of CYAD-101.

The expansion segment of the study will then evaluate three injections of CYAD-101 at the RecD defined in the first segment, administered concurrently with FOLFOX, in a larger number of patients.

The Phase I dose-escalation segment will enroll a maximum of 18 patients (6 patients maximum per cohort in case of DLT) and the phase I expansion segment 18-21 additional patients. Patients from the dose escalation segment enrolled in the dose-level selected for expansion segment will be considered as part of the expansion segment for the statistical analyses. A maximum of 36 patients will be enrolled in the global Phase I study.

The only chemotherapy regimen accepted in this protocol is the FOLFOX (5-FU, leucovorin and oxaliplatin). This chemotherapy regimen is one of the recommended standard regimens for this stage. The FOLFOX regimen will be administered according to a two-week cycle schedule.

Clinical Study Identifier: NCT03692429

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