LCAR-F33S in Treatment of Relapsed/Refractory Multiple Myeloma
NCT ID: NCT07100067
Last Updated: 2025-12-29
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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RECRUITING
NA
35 participants
INTERVENTIONAL
2025-09-16
2029-11-20
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LCAR-F33S
Each subject will be given a single-dose LCAR- F33S cells infusion at each dose level.
LCAR- F33S cells intravenous infusion
Prior to infusion of the LCAR- F33S cell, Subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.
Interventions
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LCAR- F33S cells intravenous infusion
Prior to infusion of the LCAR- F33S cell, Subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.
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 treatment with one PI, one IMiD and a CD38 monoclonal antibody.
* 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 Plasma cell leukemia, 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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Institute of Hematology & Blood Diseases Hospital, China
OTHER
Nanjing Legend Biotech Co.
INDUSTRY
Responsible Party
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Principal Investigators
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Lugui Qiu, MD
Role: PRINCIPAL_INVESTIGATOR
Institute of Hematology & Blood Diseases Hospital, China
Locations
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Beijing Boren Hospital
Beijing, , China
Institute of Hematology & Blood Diseases Hospital
Tianjin, , China
Institute of Hematology & Blood Diseases Hospital
Tianjin, , China
Wuhan Union Hospital
Wuhan, , China
Countries
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Central Contacts
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Facility Contacts
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Yajing Zhang, MD
Role: primary
Lugui Qiu, MD
Role: primary
Gang An, MD
Role: primary
Heng Mei, MD
Role: primary
Other Identifiers
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LB2502-0001
Identifier Type: -
Identifier Source: org_study_id