Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06298266
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-02-29
Brief Title:
To Assess Safety Tolerability and Efficacy of Anti-GPRC5D-CD19-CAR-T in RelapsedRefractory Multiple Myeloma
Sponsor:
Guangdong Second Provincial General Hospital
Organization:
Guangdong Second Provincial General Hospital
Study Overview
Official Title:
Clinical Study to Evaluate the Safety Tolerability and Initial Efficacy of Anti-GPRC5D-CD19-CAR-T in Patients With RelapsedRefractory 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?:
None