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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Relapse/Refractory Multiple Myeloma

Intervention / Treatment
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* Biological: CYAD-211
* Drug: Endoxan
* Drug: Fludara


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CYAD-211<br>Infusion post preconditioning non-myeloablative chemotherapy | Biological: CYAD-211<br>* Allogeneic anti-BCMA chimeric antigen receptor (CAR) T-cell<br>Drug: Endoxan<br>* Preconditioning chemotherapy<br>* Other names: cyclophosphamide;Drug: Fludara<br>* Preconditioning chemotherapy<br>* Other names: Fludarabine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Dose Limiting Toxicities | Occurrence of Dose Limiting Toxicities | Up to 36 days post-infusion. |