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Clinical Trial 20753

Cancer Type: Multiple Myeloma
Study Type: Treatment
NCT#: NCT04613557

Phase: Phase I
Principal Investigator: Nishihori, Taiga

Call 813-745-6100
or 1-800-679-0775 Learn More
Overview

Study Title

An Open-Label Phase I, Multi-Center Study to Determine the Recommended Dose of the Chimeric Antigen Receptor T-cell Treatment CYAD-211 After a Non-Myeloablative Preconditioning Chemotherapy in Multiple Myeloma Patients with Relapsed or Refractory Disease (IMMUNICY-1)

Summary

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.

Objective

Primary Objective: The primary objective of this Phase I study is to determine the recommended dose (RecD) for the CYAD-211 investigational product when administered as a single infusion after a non-myeloablative preconditioning chemotherapy in MM patients with relapsed or refractory disease. Secondary Objectives: The secondary objectives of this Phase I study are: -Evaluation of additional safety parameters -Evaluation of indicators of clinical activity Exploratory Objectives: Exploratory objectives of this Phase I study are: -Kinetics of CYAD-211 in peripheral blood, bone marrow and extramedullary tumor sites/plasmacytoma -Systemic cytokine and chemokine kinetics -BCMA and other immune targets expression on normal cells and tumor cells in bone marrow, extramedullary tumor sites/plasmacytoma, and peripheral blood -soluble BCMA and other immune targets kinetics -evolution of the clonality of tumor cells in bone marrow samples or aspirate -Degree of HLA mismatching between each patient treated and CYAD-211 -Phenotype of CYAD-211 T-cells post-infusion and relative frequency of T-cell subsets -Patient's immune response against CYAD-211

Treatments

Therapies

Chemotherapy (NOS); Immunotherapy

Medications

CYAD-211 (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

Inclusion Criteria

  • 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.
  • Presence of measurable disease as per International Myeloma Working Group (IMWG) Response Criteria
  • Eastern Cooperative Oncology Group (ECOG) below or equal 2
  • Adequate hematologic, renal, hepatic, pulmonary, and cardiac function

    • Exclusion Criteria

  • History or presence of clinically relevant central nervous system (CNS) tumor involvement.
  • Autologous stem cell transplant within 12 weeks of registration or an allogeneic stem cell transplant within 6 months of starting study treatment.
  • Any investigational agent within 3 weeks prior to the initiation of the non-myeloablative preconditioning chemotherapy).
  • Prior systemic therapy for MM within 14 days prior to the initiation of the non-myeloablative preconditioning chemotherapy.
  • Prior treatment with any BCMA-targeted therapy and which has not achieved at least a partial response.

    • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.

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