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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 94 days post first study treatment administration
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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])

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

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
FOLFOX
2009
Completed Phase 3
~4560
Pembrolizumab
2017
Completed Phase 2
~2010

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
3,868 Previous Clinical Trials
5,051,965 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

Frequently Asked Questions

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

Could you provide an overview of the previous studies conducted on CYAD-101?

"The first examination of CYAD-101 occurred in 2010 at City of Hope, with approximately 267 trials completed since that point. Currently, 961 clinical studies are actively recruiting participants; a high concentration is located around Jacksonville, Florida."

Answered by AI

Has CYAD-101 gained clearance from the Federal Drug Administration?

"Taking into account that CYAD-101 is currently undergoing its initial trials, with limited data verifying safety and efficacy, our team at Power has issued a score of 1 for this drug's security."

Answered by AI

Is enrollment for this research project still available?

"Affirmative. According to information available on clinicaltrials.gov, this research study is actively seeking participants from its initial posting date of November 22nd 2021 and was last edited February 22nd 2022. A total of 34 volunteers need to be selected across 3 sites for the trial's completion."

Answered by AI

What therapeutic indications is CYAD-101 typically employed for?

"CYAD-101 is used to battle multiple malignant neoplasms and can be leveraged in cases of unresectable melanoma, microsatellite instability high tumours, or relapse after chemotherapy."

Answered by AI

What is the total sample size for this clinical investigation?

"Affirmative. Clinicaltrials.gov suggests that this project, first put up on November 22nd 2021, is actively recruiting candidates. To complete the trial, 34 participants need to be enrolled at three different sites."

Answered by AI
~10 spots leftby Mar 2025