Back to resultsalloSHRINK - Standard cHemotherapy Regimen and Immunotherapy With Allogeneic NKG2D-based CYAD-101 Chimeric Antigen Receptor T-cells (alloSHRINK)
Primary Purpose
Unresectable Metastatic Colorectal Cancer
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CYAD-101
FOLFOX
FOLFIRI
Sponsored by
About this trial
This is an interventional treatment trial for Unresectable Metastatic Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
Histologically proven metastatic adenocarcinoma of the colon or rectum.
- Confirmed metastatic unresectable adenocarcinoma of the colon or the rectum.
- Recurrent/progressing disease after at least one line of systemic therapy for metastatic disease.
- Unequivocal and measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
- FOLFOX segment: Neurotoxicity less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 from previous chemotherapy.
- 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.
- The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- The patient must have adequate bone marrow reserve, hepatic, renal, pulmonary and cardiac functions.
Exclusion Criteria:
- The patient has a confirmed or history of tumor involvement in the central nervous system (CNS).
- Any non-cancer-directed investigational agent within 3 weeks before the planned day for the first CYAD-101 administration.
- Filgrastim (Granulocyte-Colony-Stimulating Factor [G-CSF]) or similar growth factors within 7 days before the planned day for the first CYAD-101 administration.
- Prior allogeneic stem cell transplantation, chimeric antigen receptor therapy or other genetically modified T-cell therapy.
Sites / Locations
- Moffit Cancer Center
- Institut Jules BordetRecruiting
- UZ AntwerpenRecruiting
- UZ LeuvenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
CYAD-101 with FOLFOX
CYAD-101 with FOLFIRI
Arm Description
Infusion after standard FOLFOX chemotherapy
Infusion after standard FOLFIRI chemotherapy
Outcomes
Primary Outcome Measures
Occurence of Dose Limiting Toxicities
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03692429
Brief Title
alloSHRINK - Standard cHemotherapy Regimen and Immunotherapy With Allogeneic NKG2D-based CYAD-101 Chimeric Antigen Receptor T-cells
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Recruiting
Study Start Date
November 28, 2018 (Actual)
Primary Completion Date
November 28, 2021 (Anticipated)
Study Completion Date
February 17, 2036 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celyad Oncology SA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unresectable Metastatic Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
49 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CYAD-101 with FOLFOX
Arm Type
Experimental
Arm Description
Infusion after standard FOLFOX chemotherapy
Arm Title
CYAD-101 with FOLFIRI
Arm Type
Experimental
Arm Description
Infusion after standard FOLFIRI chemotherapy
Intervention Type
Drug
Intervention Name(s)
CYAD-101
Intervention Description
Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells
Intervention Type
Drug
Intervention Name(s)
FOLFOX
Intervention Description
5-FU, leucovorin and oxaliplatin
Intervention Type
Drug
Intervention Name(s)
FOLFIRI
Intervention Description
5-FU, leucovorin and irinotecan
Primary Outcome Measure Information:
Title
Occurence of Dose Limiting Toxicities
Time Frame
Up to 82 days post first CYAD-101 Infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically proven metastatic adenocarcinoma of the colon or rectum.
Confirmed metastatic unresectable adenocarcinoma of the colon or the rectum.
Recurrent/progressing disease after at least one line of systemic therapy for metastatic disease.
Unequivocal and measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
FOLFOX segment: Neurotoxicity less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 from previous chemotherapy.
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.
The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
The patient must have adequate bone marrow reserve, hepatic, renal, pulmonary and cardiac functions.
Exclusion Criteria:
The patient has a confirmed or history of tumor involvement in the central nervous system (CNS).
Any non-cancer-directed investigational agent within 3 weeks before the planned day for the first CYAD-101 administration.
Filgrastim (Granulocyte-Colony-Stimulating Factor [G-CSF]) or similar growth factors within 7 days before the planned day for the first CYAD-101 administration.
Prior allogeneic stem cell transplantation, chimeric antigen receptor therapy or other genetically modified T-cell therapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Celyad Oncology Medical Monitor, MD, PhD
Phone
+3210394100
Email
clinicaltrials@celyad.com
Facility Information:
Facility Name
Moffit Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Dae Won, MD
First Name & Middle Initial & Last Name & Degree
Kim Dae Won
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel Dubuisson
First Name & Middle Initial & Last Name & Degree
Alain Hendlisz, MD
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans Prenen, MD
First Name & Middle Initial & Last Name & Degree
Hans Prenen, MD
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hilde Marsé
First Name & Middle Initial & Last Name & Degree
Eric Van Cutsem, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35191428
Citation
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.
Results Reference
derived
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alloSHRINK - Standard cHemotherapy Regimen and Immunotherapy With Allogeneic NKG2D-based CYAD-101 Chimeric Antigen Receptor T-cells
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