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
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Celyad Oncology SA
- Enrollment
- 18
- Locations
- 5
- Primary Endpoint
- Occurrence of Dose Limiting Toxicities
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
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.
Arms & Interventions
CYAD-211
Infusion post preconditioning non-myeloablative chemotherapy
Intervention: CYAD-211 (Biological)
CYAD-211
Infusion post preconditioning non-myeloablative chemotherapy
Intervention: Endoxan (Drug)
CYAD-211
Infusion post preconditioning non-myeloablative chemotherapy
Intervention: Fludara (Drug)
Outcomes
Primary Outcomes
Occurrence of Dose Limiting Toxicities
Time Frame: Up to 36 days post-infusion.
Occurrence of Dose Limiting Toxicities
Secondary Outcomes
No secondary outcomes reported