Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06333509
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-02-19
Brief Title:
Anti-GPRC5D CAR-T Cells CT071 in Participants With RRMM or RRpPCL
Sponsor:
CARsgen Therapeutics Co Ltd
Organization:
CARsgen Therapeutics Co Ltd
Study Overview
Official Title:
A Phase 12 Open Label Study to Evaluate the Safety and Efficacy of CT071 an Autologous Anti-GPRC5D CAR T in RelapsedRefractory Multiple Myeloma RRMM or RelapsedRefractory Primary Plasma Cell Leukemia RRpPCL
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:
A Phase 12 Open label multicenter clinical trial of autologous CAR T-cell therapy targeting GPRC5D in participants with relapsedrefractory multiple myeloma or relapsedrefractory primary plasma cell leukemia
Detailed Description:
This is an open-label multicenter Phase 12 trial of CT071 in adult participants with relapsed or refractory multiple myeloma RRMM or relapsed or refractory primary plasma cell leukemia RRpPCL
The study will be conducted in two phases Phase 1 of the study will be dose escalation followed by dose expansion After recommended Phase 2 dose is identified in Phase 1 the enrollment of Phase 2 will start Following consent enrolled subjects will undergo apheresis to collect cells for manufacture of the CAR-T cells Following the manufacture of the CAR-T cells subjects will receive lymphodepletion prior to CAR T-cell infusion All subjects who complete the study as well as those who withdraw from the study after receiving CAR T-cell infusion for reasons other than death or meeting the early termination criteria will be asked to undergo a 15-year long-term follow-up
The study will be conducted in two phases Phase 1 of the study will be dose escalation followed by dose expansion After recommended Phase 2 dose is identified in Phase 1 the enrollment of Phase 2 will start Following consent enrolled subjects will undergo apheresis to collect cells for manufacture of the CAR-T cells Following the manufacture of the CAR-T cells subjects will receive lymphodepletion prior to CAR T-cell infusion All subjects who complete the study as well as those who withdraw from the study after receiving CAR T-cell infusion for reasons other than death or meeting the early termination criteria will be asked to undergo a 15-year long-term follow-up
Study Oversight
Has Oversight DMC:
None
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?:
False
Is an FDA AA801 Violation?:
None