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

An Open-label, Phase I Study to Assess the Safety of Multiple Doses of CYAD-101, Administered After Standard FOLFOX or FOLFIRI Chemotherapy in Patients With Unresectable Metastatic Colorectal Cancer

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

Study Overview

• Status: Recruiting
• Conditions: Unresectable Metastatic Colorectal Cancer
• Intervention / Treatment: Drug: CYAD-101; Drug: FOLFOX; Drug: FOLFIRI

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 Type: Interventional
• Enrollment (Anticipated): 49
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1000
    • Recruiting
    • Institut Jules Bordet
    • Principal Investigator: Alain Hendlisz, MD
  • Edegem, Belgium, 2650
    • Recruiting
    • UZ Antwerpen
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Leuven
• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Not yet recruiting
      • Moffit Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CYAD-101 with FOLFOX; Infusion after standard FOLFOX chemotherapy	Drug: CYAD-101; Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells; Drug: FOLFOX; 5-FU, leucovorin and oxaliplatin
EXPERIMENTAL: CYAD-101 with FOLFIRI; Infusion after standard FOLFIRI chemotherapy	Drug: CYAD-101; Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells; Drug: FOLFIRI; 5-FU, leucovorin and irinotecan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurence of Dose Limiting Toxicities	Up to 82 days post first CYAD-101 Infusion

Collaborators and Investigators

• Sponsor: Celyad Oncology SA

Publications and helpful links

General Publications

• Michaux A, Mauen S, Breman E, Dheur MS, Twyffels L, Saerens L, Jacques-Hespel C, Gauthy E, Agaugue S, Gilham DE, Sotiropoulou PA. Clinical Grade Manufacture of CYAD-101, a NKG2D-based, First in Class, Non-Gene-edited Allogeneic CAR T-Cell Therapy. J Immunother. 2022 Apr 1;45(3):150-161. doi: 10.1097/CJI.0000000000000413.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 28, 2018
• Primary Completion (ANTICIPATED): November 28, 2021
• Study Completion (ANTICIPATED): February 17, 2036

Study Registration Dates

• First Submitted: August 31, 2018
• First Submitted That Met QC Criteria: October 1, 2018
• First Posted (ACTUAL): October 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 19, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CYAD-N2L-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No