Clinical Trials /

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

NCT04613557

Description:

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

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Safety, Activity and Cell Kinetics of CYAD-211 in Patients With Relapsed or Refractory Multiple Myeloma
  • Official Title: Open-label Phase I, Multi-center Study to Determine the Recommended Dose of CYAD-211 After a Non-myeloablative Preconditioning Chemotherapy in Multiple Myeloma Patients With Relapsed or Refractory Disease

Clinical Trial IDs

  • ORG STUDY ID: CYAD-211-001
  • NCT ID: NCT04613557

Conditions

  • Relapse/Refractory Multiple Myeloma

Interventions

DrugSynonymsArms
CYAD-211CYAD-211
EndoxancyclophosphamideCYAD-211
FludaraFludarabineCYAD-211

Purpose

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

Detailed Description

      This study aims to determine the recommended dose of the allogeneic CYAD-211 (anti-BCMA
      CAR-T) cells after a non-myeloablative preconditioning chemotherapy in multiple myeloma (MM)
      patients with relapsed or refractory disease.
    

Trial Arms

NameTypeDescriptionInterventions
CYAD-211ExperimentalInfusion post preconditioning non-myeloablative chemotherapy
  • CYAD-211
  • Endoxan
  • Fludara

Eligibility Criteria

        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) pathology.

          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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Occurrence of Dose Limiting Toxicities
Time Frame:Up to 36 days post-infusion.
Safety Issue:
Description:Occurrence of Dose Limiting Toxicities

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Celyad Oncology SA

Last Updated

November 2, 2020