LCAR-M61S and LCAR-M61D in Treatment of Relapsed/Refractory Multiple Myeloma
NCT06472479 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66
Last updated 2024-06-28
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 relapsed/refractory multiple myeloma.
Conditions
Interventions
- BIOLOGICAL
-
LCAR-M61S cells preparation
Biological: LCAR-M61S or LCAR-M61D cells intravenous infusion; Prior to infusion of the LCAR-M61S and LCAR-M61D cell preparation, Subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.
- BIOLOGICAL
-
LCAR-M61D cells preparation
Biological: LCAR-M61S or LCAR-M61D cells intravenous infusion; Prior to infusion of the LCAR-M61S and LCAR-M61D cell preparation, Subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.
Sponsors & Collaborators
-
Nanjing Legend Biotech Co.
collaborator INDUSTRY -
The First Affiliated Hospital with Nanjing Medical University
lead OTHER
Principal Investigators
-
Lijuan Chen · The First Affiliated Hospital with Nanjing Medical University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-01
- Primary Completion
- 2028-08-22
- Completion
- 2029-10-12
Countries
- China
Study Locations
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