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

Unresectable Metastatic Colorectal Cancer Clinical Trial

— alloSHRINK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03692429
• Other study ID #: CYAD-N2L-101
• Status: Recruiting
• Phase: Phase 1
• Start date: November 28, 2018
• Est. completion date: February 17, 2036

Study information

• Verified date: November 2020
• Source: Celyad Oncology SA
• Contact: Celyad Oncology Medical Monitor, MD, PhD
• Phone: +3210394100
• Email: clinicaltrials[@]celyad.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 49
• Est. completion date: February 17, 2036
• Est. primary completion date: November 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Unresectable Metastatic Colorectal Cancer

Intervention

Drug:
• CYAD-101
Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells
• FOLFOX
5-FU, leucovorin and oxaliplatin
• FOLFIRI
5-FU, leucovorin and irinotecan

Locations

Country	Name	City	State
Belgium	Institut Jules Bordet	Brussels
Belgium	UZ Antwerpen	Edegem
Belgium	UZ Leuven	Leuven
United States	Moffit Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Celyad Oncology SA

Countries where clinical trial is conducted

United States,  Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of Dose Limiting Toxicities		Up to 82 days post first CYAD-101 Infusion