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NCT03692429 | RECRUITING | Unresectable Metastatic Colorectal Cancer

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

Celyad oncology to

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

Unresectable Metastatic Colorectal Cancer

Intervention/treatment

CYAD-101

FOLFOX

FOLFIRI

Phase

PHASE1

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 Type : INTERVENTIONAL
Estimated Enrollment : 49 participants
Masking : NONE
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 : 2018-11-28
Estimated Primary Completion Date : 2021-11-28
Estimated Study Completion Date : 2036-02-17

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
alloSHRINK - Standard cHemotherapy Regimen and Immunotherapy With Allogeneic NKG2D-based CYAD-101 Chimeric Antigen Receptor T-cells

Location Details

NCT03692429

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, Florida

Moffit Cancer Center

Tampa, Florida, United States, 33612

RECRUITING

Belgium,

Institute Jules Table

Brussels, Belgium, 1000

RECRUITING

Belgium,

UZ Antwerp

Edegem, Belgium, 2650

RECRUITING

Belgium,

UZ Leuven

Leuven, Belgium, 3000