Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-30 @ 3:34 AM
Study NCT ID:
NCT06298266
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-02-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Assess Safety, Tolerability, and Efficacy of Anti-GPRC5D-CD19-CAR-T in Relapsed/Refractory Multiple Myeloma
Sponsor:
Guangdong Second Provincial General Hospital
Organization:
Study Overview
Official Title:
Clinical Study to Evaluate the Safety, Tolerability and Initial Efficacy of Anti-GPRC5D-CD19-CAR-T in Patients With Relapsed/Refractory Multiple Myeloma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
To evaluate the safety and tolerability of anti-GPRC5D-CD19 CAR-T cells infusion in subjects with relapsed and refractory multiple myeloma
Detailed Description:
This study is a single-arm, single-center clinical study of IIT to evaluate the safety, tolerability, pharmacokinetic profile, and initial efficacy of GPRC5D-CD19 CAR T cells in subjects with MM. The safety of GPRC5D-CD19 CAR T was evaluated by observing adverse events after cell therapy. Evaluate the effectiveness of GPRC5D-CD19 CAR T treatment compared to the results of the subjects' own previous standard treatment regimens or base data. Blood and bone marrow were collected before and 24 months after the GPRC5D-CD19 CAR T infusion to detection.
Study Oversight
Has Oversight DMC:
None
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?: