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

Phase 1

Active, not recruiting

• Conditions: Relapse/Refractory Multiple Myeloma
• Interventions: Biological: CYAD-211; Drug: Endoxan; Drug: Fludara

• Registration Number: NCT04613557
• Lead Sponsor: Celyad Oncology SA

Brief 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

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.

Study Timeline

• Study First Submitted: 2020-10-28
• Study First Submitted QC: 2020-11-02
• Study First Posted: 2020-11-03
• Study Start: 2020-11-16
• Primary Completion: 2022-12-21
• Status Verified: 2023-06
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-08-31
• Study Completion: 2037-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
CYAD-211	CYAD-211	Infusion post preconditioning non-myeloablative chemotherapy
CYAD-211	Endoxan	Infusion post preconditioning non-myeloablative chemotherapy
CYAD-211	Fludara	Infusion post preconditioning non-myeloablative chemotherapy

Primary Outcome Measures

Name	Time	Method
Occurrence of Dose Limiting Toxicities	Up to 36 days post-infusion.	Occurrence of Dose Limiting Toxicities

Trial Locations

Locations (5)

Universitair Ziekenhuis Antwerpen; 🇧🇪 Antwerp, Belgium

Institut Jules Bordet; 🇧🇪 Brussels, Belgium

Nyu Langone Hospitals; 🇺🇸 New York, New York, United States

H. Lee Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

AZ DELTA; 🇧🇪 Roeselare, Belgium