Study in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Patients to Determine the Recommended Dose of CYAD-02

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Celyad Oncology SA
Study ID
NCT04167696
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CYAD-02 — BIOLOGICAL
    CYAD-02 is a Chimeric Antigen Receptor-T (CAR-T) administered after CYFLU.
  • ENDOXAN — DRUG
    administered as preconditioning chemotherapy
  • Fludara — DRUG
    administered as preconditioning chemotherapy

Study Details

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.

Key Dates

Start date
Nov 25, 2019
Status verified
Jun 2020
Primary completion
Dec 31, 2021
Completion
Feb 28, 2035

Study Design

Enrollment
27 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Dose Level 1
    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.
  • Experimental: Dose Escalation Dose Level 2
    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.
  • Experimental: Dose Escalation Dose Level 3
    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.

Primary Outcome Measure

Occurrence of Dose Limiting Toxicities as defined per protocol in order to define the final recommended dose. [ Time Frame: from start the first infusion of CYAD-02 (Day1) up to Day36. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo Clinic Cancer CenterJacksonvilleFlorida32224
Mohamed Kharfan Dabaja, MD
904-953-3376
Mohamed Kharfan Dabaja, MD (PRINCIPAL_INVESTIGATOR)
University of Kansas Cancer CenterFairwayKansas66205
Tara LIN, MD
913-945-5052
Tara LIN, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Jacksonville, FL

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Mayo Clinic Cancer Center· Jacksonville, FLUniversity of Kansas Cancer Center· Fairway, KS

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