Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06271252
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-01-26
Brief Title:
A Study to Evaluate the Safety PKPD of OriCAR-017 in Subjects With RRMM - RIGEL Study
Sponsor:
OriCell Therapeutics Co Ltd
Organization:
OriCell Therapeutics Co Ltd
Study Overview
Official Title:
A Phase III Open-label Multicenter Study to Evaluate the Safety Pharmacokinetics Pharmacodynamics and Preliminary Efficacy of Anti-GPRC5D CAR-T Cell Product OriCAR-017 in Subjects With RelapsedRefractory Multiple Myeloma
Status:
RECRUITING
Status Verified Date:
2024-08
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:
The is a first clinical study for Oricell Therapeutics Inc in the United States to evaluate the safety PK PD and preliminary efficacy of our anti-GPRC5D cell product OriCAR-017 in subjects with relapsedrefractory multiple myeloma
RIGEL Study
RIGEL Study
Detailed Description:
This is a Phase III open-label multicenter study to evaluate the safety pharmacokinetics pharmacodynamics and preliminary efficacy of anti-GPRC5D CAR-T cell product OriCAR-017 in subjects with relapsedrefractory multiple myeloma The study will consist of a Phase I dose escalation stage involving three doses as a single IV infusion with up to 18 evaluable subjects and a dose expansion stage with 10-15 evaluable subjects followed by a Phase II stage with up to 48 evaluable subjects
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?:
None
Is an FDA AA801 Violation?:
None