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

Phase 1

Recruiting

• Conditions: Unresectable Metastatic Colorectal Cancer
• Interventions: Drug: CYAD-101; Drug: FOLFOX; Drug: FOLFIRI

• Registration Number: NCT03692429
• Lead Sponsor: Celyad Oncology SA

Brief 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

Detailed Description

This Study aims to determine and confirm the recommended dose of the allogeneic CYAD-101 cells after standard FOLFOX or FOLFIRI chemotherapy in patients with unresectable metastatic colorectal cancer

Study Timeline

• Study First Submitted: 2018-08-31
• Study First Submitted QC: 2018-10-01
• Study First Posted: 2018-10-02
• Study Start: 2018-11-28
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-19
• Last Update Posted: 2020-11-20
• Primary Completion: 2021-11-28
• Study Completion: 2036-02-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 49

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
CYAD-101 with FOLFOX	CYAD-101	Infusion after standard FOLFOX chemotherapy
CYAD-101 with FOLFOX	FOLFOX	Infusion after standard FOLFOX chemotherapy
CYAD-101 with FOLFIRI	CYAD-101	Infusion after standard FOLFIRI chemotherapy
CYAD-101 with FOLFIRI	FOLFIRI	Infusion after standard FOLFIRI chemotherapy

Primary Outcome Measures

Name	Time	Method
Occurence of Dose Limiting Toxicities	Up to 82 days post first CYAD-101 Infusion

Trial Locations

Locations (4)

UZ Antwerpen; 🇧🇪 Edegem, Belgium

Moffit Cancer Center; 🇺🇸 Tampa, Florida, United States

Institut Jules Bordet; 🇧🇪 Brussels, Belgium

UZ Leuven; 🇧🇪 Leuven, Belgium