Study in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Patients to Determine the Recommended Dose of CYAD-02 — CYCLE-1

Acute Myeloid Leukemia Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

This open-label phase I, multi-center study aims 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 CYAD-02 consolidation cycle for non-progressive patients.

During dose escalation, three prespecified dose-levels of CYAD-02 will be evaluated in three cohorts. Patient enrollment during dose-escalation will be staggered according to the Fibonacci 3+3 design and extension of cohorts II and III will be done in parallel. The first CYAD-02 infusion will be administered after prior non-myeloablative preconditioning chemotherapy (CYFLU) administered on three consecutive days.

Non-progressive patients meeting the criteria specified below may receive a consolidation cycle with three additional CYAD-02 infusions at a 2-week interval without prior preconditioning.

For all patients who received at least one CYAD-02 infusion, the overall study duration will be approximately 15 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04167696
Study type	Interventional
Source	Celyad (formerly named Cardio3 BioSciences)
Contact	Frederic LEHMANN, MD, PhD
Phone	003210394100
Email	flehmann@celyad.com
Status	Recruiting
Phase	Phase 1
Start date	November 25, 2019
Completion date	February 2035

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05400122` - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer	Phase 1
Recruiting	`NCT04460235` - Immunogenicity of an Anti-pneumococcal Combined Vaccination in Acute Leukemia or Lymphoma	Phase 4
Completed	`NCT03678493` - A Study of FMT in Patients With AML Allo HSCT in Recipients	Phase 2
Completed	`NCT04022785` - PLX51107 and Azacitidine in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome	Phase 1
Recruiting	`NCT05424562` - A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy Receiving Oral Venetoclax Tablets in Canada
Terminated	`NCT03224819` - Study of Emerfetamab (AMG 673) in Adults With Relapsed/Refractory Acute Myeloid Leukemia (AML)	Early Phase 1
Completed	`NCT03197714` - Clinical Trial of OPB-111077 in Patients With Relapsed or Refractory Acute Myeloid Leukaemia	Phase 1
Active, not recruiting	`NCT03844048` - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial	Phase 3
Active, not recruiting	`NCT04070768` - Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) and Venetoclax in Patients With Relapsed or Refractory CD33+ Acute Myeloid Leukemia:Big Ten Cancer Research Consortium BTCRC-AML17-113	Phase 1
Active, not recruiting	`NCT04107727` - Trial to Compare Efficacy and Safety of Chemotherapy/Quizartinib vs Chemotherapy/Placebo in Adults FMS-like Tyrosine Kinase 3 (FLT3) Wild-type Acute Myeloid Leukemia (AML)	Phase 2
Recruiting	`NCT04385290` - Combination of Midostaurin and Gemtuzumab Ozogamicin in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC)	Phase 1/Phase 2
Recruiting	`NCT04920500` - Bioequivalence of Daunorubicin Cytarabine Liposomes in Naive AML Patients	N/A
Recruiting	`NCT03897127` - Study of Standard Intensive Chemotherapy Versus Intensive Chemotherapy With CPX-351 in Adult Patients With Newly Diagnosed AML and Intermediate- or Adverse Genetics	Phase 3
Active, not recruiting	`NCT04021368` - RVU120 in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome	Phase 1
Recruiting	`NCT03665480` - The Effect of G-CSF on MRD After Induction Therapy in Newly Diagnosed AML	Phase 2/Phase 3
Completed	`NCT02485535` - Selinexor in Treating Patients With Intermediate- and High-Risk Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome After Transplant	Phase 1
Enrolling by invitation	`NCT04093570` - A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose), With a Food Effect Substudy at Select Study Centers	Phase 2
Recruiting	`NCT04069208` - IA14 Induction in Young Acute Myeloid Leukemia	Phase 2
Recruiting	`NCT05744739` - Tomivosertib in Relapsed or Refractory Acute Myeloid Leukemia (AML)	Phase 1
Recruiting	`NCT04969601` - Anti-Covid-19 Vaccine in Children With Acute Leukemia and Their Siblings	Phase 1/Phase 2