LCAR-F33S for relapsed or refractory multiple myeloma.
A Clinical Study to Evaluate the Safety, Tolerance and Efficacy of LCAR- F33S Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma.
This trial will test an experimental LCAR-F33S cell infusion to see if it is safe and can shrink tumors in adults with relapsed or refractory multiple myeloma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nanjing Legend Biotech Co. Industry-sponsored |
| Drugs / interventions | CAR-T, chemotherapy |
| Locations | 4 sites (Beijing and 3 other locations) |
| Trial ID | NCT07100067 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-arm, open-label dose-exploration and expansion study of LCAR-F33S in adults with relapsed or refractory multiple myeloma. Participants undergo screening, apheresis to collect cells, lymphodepleting chemotherapy, and a single intravenous infusion of LCAR-F33S, followed by scheduled follow-up visits. The study tracks safety, tolerability, pharmacokinetics, and antitumor activity across dose cohorts to identify appropriate dosing and early signs of benefit. All enrolled subjects who meet eligibility will receive the investigational cell infusion and be monitored for adverse events and response.
Who should consider this trial
Good fit: Adults (≥18) with measurable relapsed or refractory multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor, an IMiD, and a CD38 antibody, with ECOG 0–2 and expected survival ≥3 months are ideal candidates.
Not a fit: Patients who have previously received FcRH5-targeted therapy, or who have plasma cell leukemia, Waldenström macroglobulinemia, POEMS syndrome, or primary AL amyloidosis, or who cannot undergo apheresis or lymphodepleting chemotherapy are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, LCAR-F33S could produce tumor shrinkage or durable remissions for patients who have exhausted multiple standard therapies.
How similar studies have performed: Other cellular immunotherapies, notably BCMA-directed CAR-T therapies, have shown high response rates in relapsed/refractory multiple myeloma, while FcRH5-targeted cellular approaches are newer and less extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Received previous therapy targeting FcRH5 targets. * Prior antineoplastic therapy and meet exclusion criteria (before apheresis); * 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.
Where this trial is running
Beijing and 3 other locations
- Beijing Boren Hospital — Beijing, China (Not_yet_recruiting)
- Institute of Hematology & Blood Diseases Hospital — Tianjin, China (Recruiting)
- Institute of Hematology & Blood Diseases Hospital — Tianjin, China (Recruiting)
- Wuhan Union Hospital — Wuhan, China (Recruiting)
Study contacts
- Principal investigator: Lugui Qiu, MD — Institute of Hematology & Blood Diseases Hospital, China
- Study coordinator: Tingting Wang
- Email: tingting.wang@legendbiotech.cn
- Phone: +86 18618260033
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.