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CAR T-cell Therapy

CYAD-02 for Leukemia/Preleukemia (CYCLE-1 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
The patient must not be eligible for standard of care therapy and have one of the following hematological malignancy: A confirmed relapsed or refractory acute AML (i.e. ≥ 5% blasts in bone marrow or in peripheral blood) with revised European LeukemiaNet (ELN) 2017 risk stratification for favorable, intermediate or adverse groups, after at least one prior therapy defined as either Recurrence of disease after a first complete remission and not eligible for a second course of induction therapy, or Recurrence of disease after a second complete remission, or Failure to achieve a Complete Response after induction chemotherapy.
The patient must have evaluable disease as defined by: Revised Recommendations of the International Working Group (IWG) for Diagnosis, Standardization of Response Criteria for AML patients, IWG 2006 Uniform Response Criteria for patients with MDS. The absolute peripheral blast count should be < 15,000/L.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start the first infusion of cyad-02 (day1) up to day36.
Awards & highlights

CYCLE-1 Trial Summary

This trial is testing an experimental cancer treatment on patients who have relapsed or are unresponsive to other treatments. The goal is to find the recommended dose of the treatment and to see if it helps patients. A maximum of 27 patients will be enrolled in the trial.

Who is the study for?
This trial is for patients with relapsed/refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) who can't have standard treatments. They must have had prior therapy, adequate liver and kidney function, a decent heart pump function, and acceptable lung capacity. Those with high blast counts in blood or central nervous system tumor history are excluded.Check my eligibility
What is being tested?
The study tests the safety and optimal dose of CYAD-02 after preconditioning chemotherapy with ENDOXAN and Fludara in AML/MDS patients. It's an early-phase trial aiming to enroll up to 27 participants without dose-limiting toxicities.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune cell infusion such as fever, fatigue, bone pain; effects from chemotherapy like nausea, hair loss; organ inflammation; increased risk of infection due to low blood cell counts.

CYCLE-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a type of blood cancer that has come back or didn’t respond to treatment, and I can't receive standard care.
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My blood cancer can be measured for treatment response, and my blast cell count is below 15,000/L.
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My MDS is intermediate to very high-risk or has TP53 mutation, and I didn't respond to 4 cycles of specific treatments.
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My lung function test shows mild to moderate breathing difficulty.

CYCLE-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start the first infusion of cyad-02 (day1) up to day36.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start the first infusion of cyad-02 (day1) up to day36. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Occurrence of Dose Limiting Toxicities as defined per protocol in order to define the final recommended dose.

CYCLE-1 Trial Design

3Treatment groups
Experimental Treatment
Group I: Dose Escalation Dose Level 3Experimental Treatment3 Interventions
in case of no dose limiting toxicity (DLT) and no replacement of patients,3 consecutive patients at the dose of 1x10e9 of CYAD-02 per infusion post preconditioning non-myeloablative chemotherapy according to a 3+3 study design. The preconditioning therapy consists of 3 consecutive days of cyclophosphamide (300 mg/m²/day) and fludarabine (30 mg/m²/day), two days before the CYAD-02 infusion. In case of no progression at D22, the patient is eligible to receive a consolidation cycle of 3 additional CYAD-02 infusion at the same dose level, without prior preconditioning chemotherapy.
Group II: Dose Escalation Dose Level 2Experimental Treatment3 Interventions
in case of no dose limiting toxicity (DLT) and no replacement of patients,3 consecutive patients at the dose of 3x10e8 of CYAD-02 per infusion post preconditioning non-myeloablative chemotherapy according to a 3+3 study design. The preconditioning therapy consists of 3 consecutive days of cyclophosphamide (300 mg/m²/day) and fludarabine (30 mg/m²/day), two days before the CYAD-02 infusion. In case of no progression at D22, the patient is eligible to receive a consolidation cycle of 3 additional CYAD-02 infusion at the same dose level, without prior preconditioning chemotherapy.
Group III: Dose Escalation Dose Level 1Experimental Treatment3 Interventions
in case of no dose limiting toxicity (DLT) and no replacement of patients, 3 consecutive patients at the dose of 1x10e8 of CYAD-02 per infusion post preconditioning non-myeloablative chemotherapy according to a 3+3 study design. The preconditioning therapy consists of 3 consecutive days of cyclophosphamide (300 mg/m²/day) and fludarabine (30 mg/m²/day), two days before the CYAD-02 infusion. In case of no progression at D22, the patient is eligible to receive a consolidation cycle of 3 additional CYAD-02 infusion at the same dose level, without prior preconditioning chemotherapy.

Find a Location

Who is running the clinical trial?

Celyad Oncology SALead Sponsor
12 Previous Clinical Trials
1,272 Total Patients Enrolled

Media Library

CYAD-02 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04167696 — Phase 1
Myelodysplastic Syndrome Research Study Groups: Dose Escalation Dose Level 1, Dose Escalation Dose Level 2, Dose Escalation Dose Level 3
Myelodysplastic Syndrome Clinical Trial 2023: CYAD-02 Highlights & Side Effects. Trial Name: NCT04167696 — Phase 1
CYAD-02 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04167696 — Phase 1

Frequently Asked Questions

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

How many participants are currently taking part in this clinical experiment?

"Affirmative, the information available on clinicaltrials.gov implies that this medical trial is actively seeking participants. This experiment was first posted in late November 2019 and has since been updated in early June 2020. The researchers are looking for 27 volunteers at two distinct sites."

Answered by AI

What symptoms does CYAD-02 typically alleviate?

"CYAD-02 has been approved to treat multiple sclerosis, mixed-cell type lymphoma and acute myelocytic leukemia."

Answered by AI

Is there currently an opportunity to participate in this clinical research?

"As per the clinicaltrials.gov entry, this medical trial is still enrolling eligible patients. The initial post date was November 25th 2019 and the most recent edit occurred on June 8th 2020."

Answered by AI

Are there any analogous studies to CYAD-02 that have been conducted previously?

"Right now, a whopping 889 studies are being conducted on CYAD-02. Of those, 161 have progressed to Phase 3 trials while the remainder remain in earlier stages of research. Most of these clinical trial sites can be found around Philadelphia; however, there is also representation in 28444 other locations worldwide."

Answered by AI

Has CYAD-02 achieved official sanction from the Food and Drug Administration?

"CYAD-02's safety has been evaluated with a score of 1 due to the fact that only preliminary data confirming its efficacy and security is available at this point in time."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Patients to Determine the Recommended Dose of CYAD-02
2019. "Study in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Patients to Determine the Recommended Dose of CYAD-02". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04167696.
~5 spots leftby May 2025
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