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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
Must not have
The patient has a confirmed or history of tumor involvement in the central nervous system (CNS)
Prior allogeneic stem cell transplantation, chimeric antigen receptor therapy or other genetically modified T-cell therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is a type of colon or rectal cancer that has spread.
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My cancer in the colon or rectum cannot be removed by surgery and has spread.
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My cancer has returned or worsened after treatment for its spread.
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I have mild or no nerve damage from past chemotherapy.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My heart, liver, kidneys, lungs, and bone marrow are working well.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer has spread to my brain or spinal cord.
Select...
I have had a stem cell transplant or gene-modified T-cell therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Find a Location
Who is running the clinical trial?
Celyad Oncology SALead Sponsor
12 Previous Clinical Trials
1,250 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is a type of colon or rectal cancer that has spread.My cancer in the colon or rectum cannot be removed by surgery and has spread.My cancer has returned or worsened after treatment for its spread.I have mild or no nerve damage from past chemotherapy.I am fully active or restricted in physically strenuous activity but can do light work.My cancer progressed despite FOLFIRI treatment within the last 3 months.My heart, liver, kidneys, lungs, and bone marrow are working well.My cancer has spread to my brain or spinal cord.I haven't taken Filgrastim or similar drugs in the last 7 days.I have had a stem cell transplant or gene-modified T-cell therapy.
Research Study Groups:
This trial has the following groups:- Group 1: CYAD-101 with FOLFOX
- Group 2: CYAD-101 with FOLFIRI
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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