Clinical Trial 20753

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

Phase: Phase I
Principal Investigator: Nishihori, Taiga

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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

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.

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