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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03692429
Recruitment Status : Recruiting
First Posted : October 2, 2018
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Celyad Oncology SA

Study Description
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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
Unresectable Metastatic Colorectal Cancer Drug: CYAD-101 Drug: FOLFOX Drug: FOLFIRI 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 28, 2018
Estimated Primary Completion Date : November 28, 2021
Estimated Study Completion Date : February 17, 2036
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Occurence of Dose Limiting Toxicities [ Time Frame: Up to 82 days post first CYAD-101 Infusion ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03692429


Contacts
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Contact: Celyad Oncology Medical Monitor, MD, PhD +3210394100 clinicaltrials@celyad.com

Locations
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United States, Florida
Moffit Cancer Center Not yet recruiting
Tampa, Florida, United States, 33612
Contact: Kim Dae Won, MD         
Principal Investigator: Kim Dae Won         
Belgium
Institut Jules Bordet Recruiting
Brussels, Belgium, 1000
Contact: Michel Dubuisson         
Principal Investigator: Alain Hendlisz, MD         
UZ Antwerpen Recruiting
Edegem, Belgium, 2650
Contact: Hans Prenen, MD         
Principal Investigator: Hans Prenen, MD         
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Hilde Marsé         
Principal Investigator: Eric Van Cutsem, MD         
Sponsors and Collaborators
Celyad Oncology SA
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Celyad Oncology SA
ClinicalTrials.gov Identifier: NCT03692429    
Other Study ID Numbers: CYAD-N2L-101
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases