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Clinical Trials in Belgium / NCT04613557
Active, not recruiting Phase 1

Safety, Activity and Cell Kinetics of CYAD-211 in Patients With Relapsed or Refractory Multiple Myeloma

NCT04613557 · tracked via the Priya Life Science Belgium tracker
Phase
Phase 1
Started
2020-11-16
Last updated
2023-08-31

Condition(s) studied

Relapse/Refractory Multiple Myeloma

Investigational drug(s) / intervention(s)

CYAD-211Endoxan →Fludara →

CYAD-211: Allogeneic anti-BCMA chimeric antigen receptor (CAR) T-cell

Endoxan: Preconditioning chemotherapy

Fludara: Preconditioning chemotherapy

Study summary

The purpose of the IMMUNICY-1 study is to assess the safety, activity and cell kinetics of CYAD-211 in adults with relapsed or refractory multiple myeloma after a lymphodepletion regimen with fludarabine and/or cyclophosphamide

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
1. Documented diagnosis of MM with relapsed or refractory disease to at least two prior MM treatment regimens which should include exposure to IMiD and PIs either alone or in combination. 2. Presence of measurable disease as per International Myeloma Working Group (IMWG) Response Criteria 3. Eastern Cooperative Oncology Group (ECOG) below or equal 2 4. Adequate hematologic, renal, hepatic, pulmonary, and cardiac function Exclusion Criteria: 1. History or presence of clinically relevant central nervous system (CNS) tumor involvement. 2. Autologous stem cell transplant within 12 weeks of registration or an allogeneic stem cell transplant within 6 months of starting study treatment. 3. Any investigational agent within 3 weeks prior to the initiation of the non-myeloablative preconditioning chemotherapy). 4. Prior systemic therapy for MM within 14 days prior to the initiation of the non-myeloablative preconditioning chemotherapy. 5. Prior treatment with any BCMA-targeted therapy and which has not achieved at least a partial response.

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
H. Lee Moffitt Cancer Center Tampa Florida
Nyu Langone Hospitals New York New York
Universitair Ziekenhuis Antwerpen Antwerp Belgium
Institut Jules Bordet Brussels Belgium
AZ DELTA Roeselare Belgium

More Celyad Oncology SA trials in Belgium

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04613557 on ClinicalTrials.gov ↗ ← All trials in Belgium