Tests LCAR-F33S cell therapy in adults with relapsed or refractory multiple myeloma
Tests LCAR-F33S cell therapy in adults with multiple myeloma that has returned or not responded.
Plain-language title generated from the registry record
Registry title: LCAR-F33S in Treatment of Relapsed/Refractory Multiple Myeloma
Key facts
- Where
- Beijing, Tianjin, and Wuhan, ChinaSee the 3 sites
Where in China
- Beijing Boren HospitalBeijing, ChinaNot yet recruiting
- Institute of Hematology & Blood Diseases HospitalTianjin, ChinaTaking people
- Wuhan Union HospitalWuhan, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Nanjing Legend Biotech Co.
- Trial code
- NCT07100067
- Record updated
- 29 December 2025
- Original description
A prospective, single-arm, open-label dose-exploration and expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of LCAR-F33S in patients with relapsed/refractory multiple myeloma(Investigator-initiated Study).Read full original descriptionShow less
A Clinical Study to Evaluate the Safety, Tolerance and Efficacy of LCAR- F33S Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma.
A prospective, single-arm, open-label dose-exploration and expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of LCAR-F33S in patients with relapsed/refractory multiple myeloma(Investigator-initiated Study).
Inclusion: Subjects voluntarily participate in clinical research; 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: Received previous therapy targeting FcRH5 targets; Prior antineoplastic therapy and meet exclusion criteria (before apheresis); Female subjects who were pregnant, breastfeeding, or planning to become pregnant while participating in this study or within 1 year of receiving study treatment; 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; Also enrolled in other clinical studies.