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

Sponsor
Celyad Oncology SA (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03692429
Collaborator
(none)
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Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
49 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 28, 2018
Anticipated Primary Completion Date :
Nov 28, 2021
Anticipated Study Completion Date :
Feb 17, 2036

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Occurence of Dose Limiting Toxicities [Up to 82 days post first CYAD-101 Infusion]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Histologically proven metastatic adenocarcinoma of the colon or rectum.

  2. Confirmed metastatic unresectable adenocarcinoma of the colon or the rectum.

  3. Recurrent/progressing disease after at least one line of systemic therapy for metastatic disease.

  4. Unequivocal and measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).

  5. FOLFOX segment: Neurotoxicity less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 from previous chemotherapy.

  6. 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.

  7. The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

  8. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Moffit Cancer Center Tampa Florida United States 33612
2 Institut Jules Bordet Brussels Belgium 1000
3 UZ Antwerpen Edegem Belgium 2650
4 UZ Leuven Leuven Belgium 3000

Sponsors and Collaborators

  • Celyad Oncology SA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Celyad Oncology SA
ClinicalTrials.gov Identifier:
NCT03692429
Other Study ID Numbers:
  • CYAD-N2L-101
First Posted:
Oct 2, 2018
Last Update Posted:
Nov 20, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 20, 2020