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

Relapse/Refractory Multiple Myeloma Clinical Trial

— IMMUNICY-1  

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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04613557
• Other study ID #: CYAD-211-001
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: November 16, 2020
• Est. completion date: February 2037

Study information

• Verified date: June 2023
• Source: Celyad Oncology SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: February 2037
• Est. primary completion date: December 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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) 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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapse/Refractory Multiple Myeloma

Intervention

Biological:
• CYAD-211
Allogeneic anti-BCMA chimeric antigen receptor (CAR) T-cell

Drug:
• Endoxan
Preconditioning chemotherapy
• Fludara
Preconditioning chemotherapy

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Antwerpen	Antwerp
Belgium	Institut Jules Bordet	Brussels
Belgium	AZ DELTA	Roeselare
United States	Nyu Langone Hospitals	New York	New York
United States	H. Lee Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Celyad Oncology SA

Countries where clinical trial is conducted

United States,  Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Dose Limiting Toxicities	Occurrence of Dose Limiting Toxicities	Up to 36 days post-infusion.