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Taking people in BelgiumPhase 1

Tests CYAD-02 dose in adults with returned acute myeloid leukemia or myelodysplastic syndrome

Tests a cell therapy, CYAD-02, after chemotherapy in adults with returned leukemia or myelodysplastic syndrome.

Key facts

Who runs it
Celyad Oncology SA
Where
Leuven, Liège, and Roeselare, BelgiumSee the 3 sitesAlso in 1 other country, 2 sites
Trial code
Registry title
Study in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Patients to Determine the Recommended Dose of CYAD-02
Status
Recruiting
Phase
Phase 1
People taking part
27 people, planned
Started
25 Nov 2019
Expected to end
Feb 2035
Type of study
Interventional, 3 groups
Treatments tested
  • CYAD-02
  • ENDOXAN
  • Fludara
Record updated
9 June 2020

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults whose acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) came back or did not respond to earlier treatment, and who cannot have standard therapy.

Age
18 years or older
Sex
Men and women can join.
Disease stage
Relapsed or refractory AML (5% or more blasts in bone marrow or blood), or MDS of intermediate, high or very high risk, or MDS with a TP53 mutation. The disease must be measurable. Blast count in the blood must be below 15,000/L.
Earlier treatment
AML: at least one earlier therapy, with relapse or no complete response. MDS: at least 4 cycles of azacitidine or decitabine that failed (no response, loss of response or intolerance). Cannot have standard-of-care therapy.
Biomarker or test result
MDS with a Tumor Protein 53 mutation found by next-generation sequencing counts as one way in. Heart ejection fraction of 40% or more is needed.

Main reasons for not taking part

  • Cancer in the central nervous system, now or in the past
  • Any other cancer therapy given to treat the cancer, or an investigational agent within 3 weeks before the first CYAD-02 infusion
  • Any positive serology test at baseline
  • Active infection, or uncontrolled serious illness
  • Serious clotting disorder or use of warfarin, heparin or direct oral anticoagulants

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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; 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

Who cannot take part

  • Patients who have received any cancer therapy with therapeutic intent (investigational agent or not)
  • 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 significant coagulation disorder or who are receiving treatment with warfarin derivatives, heparin or direct oral anticoagulants
  • Patients with a confirmed or history of tumor involvement in the central nervous system
  • Patients with uncontrolled intercurrent illness or serious uncontrolled medical disorder
  • 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
  • Patients with any positive serology test results at baseline

Where in Belgium

Also in 1 other country, 2 sites

  • UZ LeuvenLeuven, BelgiumContact: Johan MAERTENS, MDTaking people
  • CHU LiègeLiège, BelgiumContact: YVES BEGUIN, MDTaking people
  • AZ DeltaRoeselare, BelgiumContact: Dries DEEREN, MDTaking people

About the trial

What the trial wants to find out

An open-label, phase I, multi-center study to determine in relapsed/refractory (r/r) acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) patients the recommended dose of CYAD-02 after a non-myeloablative preconditioning chemotherapy followed by a potential CYAD-02 consolidation cycle for non-progressive patient. A maximum of 27 r/r AML/MDS patients will be evaluated in this study in case of no dose limiting toxicity (DLT) and no replacement of patients.

The 3 groups in the trial

  • Dose Escalation Dose Level 1Treatment being tested

    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.

    Treatment: CYAD-02, ENDOXAN, and Fludara

  • Dose Escalation Dose Level 2Treatment being tested

    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.

    Treatment: CYAD-02, ENDOXAN, and Fludara

  • Dose Escalation Dose Level 3Treatment being tested

    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.

    Treatment: CYAD-02, ENDOXAN, and Fludara

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Open-label, Phase I, Multi-center Study to Determine in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Patients the Recommended Dose of CYAD-02 After a Non-myeloablative Preconditioning Chemotherapy Followed by a Potential Consolidation Cycle
Plain-language title
Tests CYAD-02 dose in adults with returned acute myeloid leukemia or myelodysplastic syndromeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
9 June 2020