Study of CYAD-02 for Relapsed/Refractory AML or MDS
This study is testing a treatment called CYAD-02 for people with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that has come back or is not responding to other treatments. CYAD-02 is a type of cell therapy (Chimeric Antigen Receptor-T or CAR-T) given after a short course of chemotherapy (ENDOXAN and Fludara). The main goal of this study is to find the safest and most effective dose of CYAD-02. You may be eligible if you are at least 18 years old, have relapsed or refractory AML or MDS, and are not eligible for standard treatments. The study aims to enroll up to 27 patients.
- Study design
- This is an open-label, multi-center study with no specified phase, aiming to enroll up to 27 participants. It will evaluate three different dose levels of CYAD-02.
- What's involved
- You would receive preconditioning chemotherapy (ENDOXAN and Fludara) followed by an infusion of CYAD-02. Non-progressive patients may receive additional CYAD-02 infusions.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would be followed for approximately 15 years after your first CYAD-02 infusion.
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NCT04167696
Study in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Patients to Determine the Recommended Dose of CYAD-02
Recruiting
PHASE1Ages 18+InterventionalTreatmentCelyad Oncology SA
~27 participants
Updated 2020-06-09 on ClinicalTrials.gov
What's tested:CYAD-02ENDOXANFludara
At a glance
Recruiting sites
4 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of Dose Limiting Toxicities as defined per protocol in order to define the final recommended dose.
Measured over from start the first infusion of CYAD-02 (Day1) up to Day36.
Conditions
Where it's being run
5 sites across 3 statesBelgium3
Florida1
Kansas1
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
The patient must not be eligible for standard of care therapy and have one of the following hematological malignancy:
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. 2. A confirmed MDS as defined by revised International Prognostic Scoring System criteria for intermediate, high-risk or very high-risk disease or MDS with Tumor Protein 53 mutation as detected by next-generation sequencing, after failure of prior treatment with at least 4 cycles of azacitidine or decitabine defined as:
No response to treatment,
Loss of response at any time point, or
Intolerance to therapy.
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.
The patient must have adequate hepatic and renal functions, as assessed by standard laboratory criteria.
The patient must have a left ventricular ejection fraction of ≥ 40 %, as determined by echocardiography or a multigated acquisition scan.
The patient must have a Forced Expiratory Volume (FEV) in the first second /Forced Vital Capacity = 0.7 with FEV-1 at 50 % predicted (GOLD 1 or 2 severity) as determined by spirometry
Exclusion
Patients with a confirmed or history of tumor involvement in the central nervous system
Patients who have received any cancer therapy with therapeutic intent (investigational agent or not)
Patients with any positive serology test results at baseline
Patients who plan to receive, are concurrently receiving or have received any investigational agent within 3 weeks before the planned day for the first CYAD-02 infusion
Patients with uncontrolled intercurrent illness or serious uncontrolled medical disorder
Patients with significant coagulation disorder or who are receiving treatment with warfarin derivatives, heparin or direct oral anticoagulants
Patients who have active infections
Patients with documented history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis and/or active or acute exacerbation of chronic obstructive pulmonary disease
What this trial measures
- Occurrence of Dose Limiting Toxicities as defined per protocol in order to define the final recommended dose.from start the first infusion of CYAD-02 (Day1) up to Day36.