NCT03692429

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P50-P75 for phase_1

Timeline
119mo left

Started Nov 2018

Longer than P75 for phase_1

Geographic Reach
2 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Nov 2018Feb 2036

First Submitted

Initial submission to the registry

August 31, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 2, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

November 28, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2021

Completed
14.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2036

Expected
Last Updated

November 20, 2020

Status Verified

November 1, 2020

Enrollment Period

3 years

First QC Date

August 31, 2018

Last Update Submit

November 19, 2020

Conditions

Unresectable Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Occurence of Dose Limiting Toxicities

    Up to 82 days post first CYAD-101 Infusion

Study Arms (2)

CYAD-101 with FOLFOX

EXPERIMENTAL

Infusion after standard FOLFOX chemotherapy

Drug: CYAD-101Drug: FOLFOX

CYAD-101 with FOLFIRI

EXPERIMENTAL

Infusion after standard FOLFIRI chemotherapy

Drug: CYAD-101Drug: FOLFIRI

Interventions

CYAD-101DRUG

Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells

CYAD-101 with FOLFIRICYAD-101 with FOLFOX
FOLFOXDRUG

5-FU, leucovorin and oxaliplatin

CYAD-101 with FOLFOX
FOLFIRIDRUG

5-FU, leucovorin and irinotecan

CYAD-101 with FOLFIRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Moffit Cancer Center

Tampa, Florida, 33612, United States

NOT YET RECRUITING

Institut Jules Bordet

Brussels, 1000, Belgium

RECRUITING

UZ Antwerpen

Edegem, 2650, Belgium

RECRUITING

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35191428DERIVED

MeSH Terms

Interventions

Folfox protocolIFL protocol

Central Study Contacts

Celyad Oncology Medical Monitor, MD, PhD

CONTACT

+3210394100clinicaltrials@celyad.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2018

First Posted

October 2, 2018

Study Start

November 28, 2018

Primary Completion

November 28, 2021

Study Completion (Estimated)

February 17, 2036

Last Updated

November 20, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)BE(3)