RECRUITING

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

Talk to us

Conditions

Unresectable Metastatic Colorectal Cancer

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2018-11-28
Study Completion:2036-02-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03692429

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Histologically proven metastatic adenocarcinoma of the colon or rectum.
  2. 1. Confirmed metastatic unresectable adenocarcinoma of the colon or the rectum.
  3. 2. Recurrent/progressing disease after at least one line of systemic therapy for metastatic disease.
  4. 3. Unequivocal and measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
  5. 4. FOLFOX segment: Neurotoxicity less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 from previous chemotherapy.
  6. 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.
  7. 2. The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  8. 3. The patient must have adequate bone marrow reserve, hepatic, renal, pulmonary and cardiac functions.
  1. 1. The patient has a confirmed or history of tumor involvement in the central nervous system (CNS).
  2. 2. Any non-cancer-directed investigational agent within 3 weeks before the planned day for the first CYAD-101 administration.
  3. 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. 4. Prior allogeneic stem cell transplantation, chimeric antigen receptor therapy or other genetically modified T-cell therapy.

Contacts and Locations

Study Contact

Celyad Oncology Medical Monitor, MD, PhD
CONTACT
+3210394100
clinicaltrials@celyad.com

Study Locations (Sites)

Moffit Cancer Center
Tampa, Florida, 33612
United States

Collaborators and Investigators

Sponsor: Celyad Oncology SA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-11-28
Study Completion Date2036-02-17

Study Record Updates

Study Start Date2018-11-28
Study Completion Date2036-02-17

Terms related to this study

Additional Relevant MeSH Terms

  • Unresectable Metastatic Colorectal Cancer