LCAR-F33S for relapsed or refractory multiple myeloma.
Official title: A Clinical Study to Evaluate the Safety, Tolerance and Efficacy of LCAR- F33S Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma.
Run by Nanjing Legend Biotech Co. · NCT07100067 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 35 (estimated) |
| Sponsor | Nanjing Legend Biotech Co. Industry-sponsored |
| Drugs / interventions | CAR-T, chemotherapy |
| Locations | 4 sites (Beijing and 3 other locations) |
| Status | Recruiting |
| Started | September 16, 2025 |
| Main results expected | February 20, 2028 |
| Study ends | November 20, 2029 |
| Registry record updated | December 29, 2025 |
| Trial ID | NCT07100067 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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Institute of Hematology & Blood Diseases Hospital
Tianjin, China Recruiting -
Institute of Hematology & Blood Diseases Hospital
Tianjin, China Recruiting -
Wuhan Union Hospital
Wuhan, China Recruiting -
Beijing Boren Hospital
Beijing, China Not yet 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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Umbilical cord blood CAR-T cells targeting BCMA and CD19 for relapsed or refractory multiple myeloma
This trial will try an off-the-shelf CAR-T product made from umbilical cord blood that targets BCMA and CD19 in adults whose multiple myeloma has relapsed or stopped responding.
-
LUCAR-G79D for adults with relapsed or refractory lupus or inflammatory muscle disease
This trial will test an experimental CAR‑T cell treatment called LUCAR‑G79D in adults whose lupus or inflammatory muscle disease has returned or not responded to other treatments.
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LUCAR-DKS1 for relapsed or treatment-resistant autoimmune diseases
This study will try LUCAR-DKS1, a CAR-NK cell therapy, in adults (18–70) with relapsed or treatment-resistant autoimmune diseases who test positive for CD19 and/or BCMA.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.