Ignite Creation Date:
2024-07-17 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06472479
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-06
Brief Title:
LCAR-M61S and LCAR-M61D in Treatment of RelapsedRefractory Multiple Myeloma
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
The First Affiliated Hospital with Nanjing Medical University
Study Overview
Official Title:
A Clinical Study to Evaluate the Safety Tolerance and Efficacy of LCAR-M61S and LCAR-M61D Cell Preparations in Patients With RelapsedRefractory Multiple Myeloma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 prospective two-cohort open-label dose-exploration and expansion study to evaluate the safety tolerability pharmacokinetics and antitumor efficacy characteristics of LCAR-M61S and LCAR-M61D in patients with relapsedrefractory multiple myeloma
Detailed Description:
This study was a prospective two-cohort open-label clinical study to evaluate the safety tolerability pharmacokinetics and antitumor efficacy characteristics of LCAR-M61S and LCAR-M61D in patients with relapsedrefractory multiple myeloma All subjects who meet the eligibility criteria will receive intravenous injection of LCAR-M61S or LCAR-M61D cell injection The study will include the following sequential phases screening apheresis pre-treatment lymphodepleting chemotherapy treatment and follow-up
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