← Back to Search

CAR T-cell Therapy

CYAD-101 + Chemotherapy for Colorectal Cancer (alloSHRINK Trial)

Phase 1

Recruiting

Research Sponsored by Celyad Oncology SA

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically proven metastatic adenocarcinoma of the colon or rectum

Confirmed metastatic unresectable adenocarcinoma of the colon or the rectum

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 82 days post first cyad-101 infusion

Awards & highlights

alloSHRINK Trial Summary

This trial will test a new cancer treatment, CYAD-101, on patients with unresectable metastatic colorectal cancer. They will measure its safety, how it affects cancer cells, and its clinical activity.

Who is the study for?

This trial is for adults with metastatic colorectal cancer that can't be surgically removed and has worsened after treatment. They should have had FOLFIRI chemotherapy within the last 3 months, be in good physical condition (ECOG status 0 or 1), and have organs functioning well. People with brain cancer spread, recent non-cancer experimental treatments, prior cell therapies, or certain growth factor drugs can't join.Check my eligibility

What is being tested?

The alloSHRINK study tests CYAD-101 cells given after standard chemo (FOLFOX or FOLFIRI) to see how safe they are and how they affect colorectal cancer. It measures if these special immune cells can help control the disease when combined with usual treatments.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system's activation by CYAD-101 cells which may affect different organs, as well as typical chemo-related issues like nerve damage (limited for eligibility), fatigue, digestive problems, and blood count changes.

alloSHRINK Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer is a type of colon or rectal cancer that has spread.

Select...

My cancer in the colon or rectum cannot be removed by surgery and has spread.

Select...

My cancer has returned or worsened after treatment for its spread.

Select...

I have mild or no nerve damage from past chemotherapy.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Select...

My heart, liver, kidneys, lungs, and bone marrow are working well.

alloSHRINK Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 82 days post first cyad-101 infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 82 days post first cyad-101 infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 82 days post first cyad-101 infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Occurence of Dose Limiting Toxicities

alloSHRINK Trial Design

2Treatment groups

Experimental Treatment

Group I: CYAD-101 with FOLFOXExperimental Treatment2 Interventions

Infusion after standard FOLFOX chemotherapy

Group II: CYAD-101 with FOLFIRIExperimental Treatment2 Interventions

Infusion after standard FOLFIRI chemotherapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

FOLFOX

2009

Completed Phase 3

~4560

Fluorouracil

FDA approved

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Celyad Oncology SALead Sponsor

12 Previous Clinical Trials

1,250 Total Patients Enrolled

Media Library

CYAD-101 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03692429 — Phase 1

Colorectal Cancer Research Study Groups: CYAD-101 with FOLFOX, CYAD-101 with FOLFIRI

Colorectal Cancer Clinical Trial 2023: CYAD-101 Highlights & Side Effects. Trial Name: NCT03692429 — Phase 1

CYAD-101 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03692429 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any availability for participants in this medical experiment?

"Affirmative. According to clinicaltrials.gov, this medical trial is presently recruiting participants; the protocol was first posted on November 28th 2018 and last updated on November 19th 2020. 49 patients are needed from a single site for enrollment in this experiment."

Answered by AI

How many participants are contributing to this experiment?

"Affirmative, the information on clinicaltrials.gov shows that this research is searching for participants. It was initially advertised on November 28th 2018 and its details were last revised on November 19th 2020. A total of 49 participants need to be recruited from a single medical centre."

Answered by AI

Has CYAD-101 been officially sanctioned by the FDA?

"CYAD-101 remains largely untested, so safety was rated a 1. This is due to the fact that this project is currently in its first clinical trial phase and has scant evidence of effectiveness or security."

Answered by AI

What therapeutic applications does CYAD-101 possess?

"CYAD-101 is a therapeutic agent primarily used to treat rectal carcinoma, yet its efficacy extends beyond this cancer type and includes colorectal carcinoma, ovarian cancer, as well as sarcoma."

Answered by AI

Are there any other reports on the efficacy of CYAD-101?

"As of now, 507 medical studies are being conducted using CYAD-101. Of those trials, 143 have progressed to Phase 3 while the remaining 364 are in earlier stages. The majority of these clinical sites are located near Woolloongabba, Queensland with a total 24451 locations running research for this potential treatment."

Answered by AI

Recent research and studies

Journal of ImmunotherapyJournal

Clinical Grade Manufacture of CYAD-101, a Nkg2d-based, First in Class, Non–gene-edited Allogeneic CAR T-cell Therapy

Michaux, Alexandre, Sébastien Mauën, Eytan Breman, Marie-Sophie Dheur, Laure Twyffels, Laura Saerens, Céline Jacques-Hespel, et al.. 2022. “Clinical Grade Manufacture of CYAD-101, a Nkg2d-based, First in Class, Non–gene-edited Allogeneic CAR T-cell Therapy”. Journal of Immunotherapy. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/cji.0000000000000413.

clinicaltrials.govStudy

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

2018. "alloSHRINK - Standard cHemotherapy Regimen and Immunotherapy With Allogeneic NKG2D-based CYAD-101 Chimeric Antigen Receptor T-cells". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03692429.

All > Colorectal Cancer Tampa > Colorectal Cancer