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CAR T-cell Therapy

CYAD-101 + Chemotherapy and Immunotherapy for Colorectal Cancer

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
Confirmed non-microsatellite instability high (non-MSI-H)/mismatch-repair proficient (pMMR) tumor status
Histologically proven metastatic adenocarcinoma of the colon or rectum
Must not have
Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
Prior radiotherapy within 2 weeks prior to the planned day for the first study treatment administration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 94 days post first study treatment administration
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer drug, CYAD-101, given with standard chemotherapy and immunotherapy drugs, to see if it is safe and works well against colorectal cancer.

Who is the study for?
This trial is for adults with metastatic colorectal cancer that's not been surgically removed and doesn't respond to standard treatments. Participants must have had FOLFOX chemotherapy, be in good physical condition (ECOG 0 or 1), and have tumors measurable by RECIST criteria. They can't join if they've used certain growth factors, had major surgery, uncontrolled illnesses, live vaccines, anticancer agents or radiotherapy recently; or if they've ever received drugs like Pembrolizumab before.
What is being tested?
The study tests CYAD-101 cells given with FOLFOX chemo followed by Pembrolizumab immunotherapy in patients with advanced colorectal cancer. It aims to see how safe this combination is and whether it works against the cancer.
What are the potential side effects?
Possible side effects include reactions from the immune system attacking normal organs (like lung inflammation), infusion-related reactions from treatment administration, fatigue, nausea from chemo, nerve damage symptoms remaining from previous treatments but not worsening.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tumor does not have high microsatellite instability.
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My cancer is a type of colon or rectal cancer that has spread.
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I have mild or no nerve damage from past chemotherapy.
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I am scheduled to receive FOLFOX chemotherapy.
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My cancer in the colon or rectum cannot be removed by surgery.
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I am fully active or can carry out light work.
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My cancer came back or got worse after treatment including FOLFOX.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with specific immune therapy drugs before.
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I have not had radiotherapy in the last 2 weeks.
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I have not received a live vaccine in the last 30 days.
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I have not had major surgery in the last 4 weeks.
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I do not have any serious illnesses that are not under control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 94 days post first study treatment administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 94 days post first study treatment administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The Occurrence of Dose Limiting Toxicities (DLT) during the 'DLT reporting period'
The objective response rate (ORR) at the tumor assessment on Day 94 [Visit 15])

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: CYAD-101 with FOLFOX Infusion administered concurrently followed by pembrolizumabExperimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~3130
FOLFOX
2009
Completed Phase 3
~4560

Find a Location

Who is running the clinical trial?

Celyad Oncology SALead Sponsor
12 Previous Clinical Trials
1,265 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,031 Previous Clinical Trials
5,189,742 Total Patients Enrolled

Media Library

CYAD-101 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04991948 — Phase 1
Colorectal Cancer Research Study Groups: CYAD-101 with FOLFOX Infusion administered concurrently followed by pembrolizumab
Colorectal Cancer Clinical Trial 2023: CYAD-101 Highlights & Side Effects. Trial Name: NCT04991948 — Phase 1
CYAD-101 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04991948 — Phase 1
~8 spots leftby Dec 2025
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