Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-01-01 @ 4:15 PM
Study NCT ID:
NCT04613557
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-31
First Post:
2020-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Activity and Cell Kinetics of CYAD-211 in Patients With Relapsed or Refractory Multiple Myeloma
Sponsor:
Celyad Oncology SA
Organization:
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMMUNICY-1
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: