Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
Study NCT ID:
NCT05759793
Status:
RECRUITING
Last Update Posted:
2025-05-20
First Post:
2023-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of CAR-GPRC5D in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia
Sponsor:
Nanjing IASO Biotechnology Co., Ltd.
Organization:
Study Overview
Official Title:
An Exploratory Study of Fully Human Anti-GPRC5D Chimeric Antigen Receptor T Cells (CAR-GPRC5D) in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia
Status:
RECRUITING
Status Verified Date:
2025-05
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:
None
Brief Summary:
This study is a single-center, open-label, dose-escalation study to observe the safety and efficacy of different doses of CAR-GPRC5D in patients with R/R MM or Plasma Cell Leukemia.
Detailed Description:
Apheresis will be performed to manufacture CAR-GPRC5D CAR-T cells. Bridging therapy is allowed between apheresis and lymphodepletion. Lymphodepletion with fludarabine and cyclophosphamide was performed for three consecutive days. Then, subjects will receive a single dose infusion of CAR-GPRC5D at 1.0, 2.0, or 3.0 x 10\^6 CAR-T cells/Kg. Subjects will be followed in the study for a minimum of 2 years after infusion. Long-term follow-up for lentiviral vector safety will be followed for up to 15 years after infusion.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: