Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-26 @ 11:45 AM
Study NCT ID:
NCT04617704
Status:
UNKNOWN
Last Update Posted:
2021-09-22
First Post:
2020-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BCMA and CD19 Targeted Fast Dual CART for Chromosomal Abnomalities High-risk BCMA+ Multiple Myeloma
Sponsor:
Shanghai Changzheng Hospital
Organization:
Study Overview
Official Title:
Exploratory Study to Evaluate Efficacy and Safety of GC012F Injection in Chromosomal Abnomalities High-risk BCMA+ Multiple Myeloma
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
NOT_YET_RECRUITING
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 is a single arm, open label, multi-center prospective study to explory the safety and efficacy of GC012F CAR-T cells in patient diagnosed with high-risk chromosomal abnormalities BCMA+ multiple myeloma(MM).
Detailed Description:
The main aim of this study is to determin the safety and efficacy of GC012F in cytogenetic high-risk MM. GC012F is an autologus dual chimeric antigen receptor T-cell(CAR-T) therapy that targets B-cell maturation antigen(BCMA) and CD19. This study comprises of a screening phase(less than or equal to 28 days prior to apheresis) followed by apheresis(will occur upon enroiiment); Treatment Phase including autologus stem cell transplant on Day-1 followed by infusion of GC012F on Day0 and then post-infusion assessments from Day1 to Day 84; and a Post-treatment Phase(Day 85 and up to end of the study). Efficacy will be explored to assessed and safety will be closely monitored during the study.
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?: