LCAR-M61S and LCAR-M61D in Treatment of Relapsed/Refractory Multiple Myeloma
NCT ID: NCT06472479
Last Updated: 2024-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
66 participants
INTERVENTIONAL
2024-07-01
2029-10-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LCAR-M61S and LCAR-M61D
Each subject will be given a single-dose LCAR-M61S or LCAR-M61D cells infusion at each dose level.
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥18 years old;
* Eastern Cooperative Oncology Group (ECOG) score 0-2;
* Examination evidence of initial diagnosis of MM according to IMWG diagnostic criteria;
* Measurable lesions were present;
* Subjects have received at least three previous lines of multiple myeloma therapy, each with at least one complete therapy cycle, unless the best response to the therapeutic regimen was documented as disease progression (PD confirmed according to IMWG criteria);
* Expected survival ≥3 months;
* Clinical laboratory values in the screening period meet criteria;
Exclusion Criteria
* Subjects had Waldenstrom macroglobulinemia, POEMS syndrome, or primary AL amyloidosis at the time of screening.
* Subjects who were positive for any of HBsAg, HBV DNA, HCV-Ab, HCV RNA, and HIV-Ab;
* Life-threatening allergic reactions, hypersensitivity reactions, or intolerance to CAR-T cell formulations or their excipients, including DMSO, are known.
* Serious underlying diseases were present;
* Female subjects who were pregnant, breastfeeding, or planning to become pregnant while participating in this study or within 1 year of receiving study treatment.
* Also enrolled in other clinical studies.
18 Years
ALL
No
Sponsors
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Nanjing Legend Biotech Co.
INDUSTRY
The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
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Chen Lijuan
Professor
Principal Investigators
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Lijuan Chen
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital with Nanjing Medical University
Locations
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Anhui Cancer Hospital
Hefei, Anhui, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Beijing Gobroad Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LB2401-0001
Identifier Type: -
Identifier Source: org_study_id
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