NCT07100067 LCAR-F33S in Treatment of Relapsed/Refractory Multiple Myeloma
| NCT ID | NCT07100067 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nanjing Legend Biotech Co. |
| Condition | Relapsed/Refractory Multiple Myeloma(MM) |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2025-09-16 |
| Primary Completion | 2028-02-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 35 participants in total. It began in 2025-09-16 with a primary completion date of 2028-02-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility 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.
Contact & Investigator
Lugui Qiu, MD
PRINCIPAL INVESTIGATOR
Institute of Hematology & Blood Diseases Hospital, China
Frequently Asked Questions
Who can join the NCT07100067 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Relapsed/Refractory Multiple Myeloma(MM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07100067 currently recruiting?
Yes, NCT07100067 is actively recruiting participants. Contact the research team at tingting.wang@legendbiotech.cn for enrollment information.
Where is the NCT07100067 trial being conducted?
This trial is being conducted at Beijing, China, Tianjin, China, Tianjin, China, Wuhan, China.
Who is sponsoring the NCT07100067 clinical trial?
NCT07100067 is sponsored by Nanjing Legend Biotech Co.. The principal investigator is Lugui Qiu, MD at Institute of Hematology & Blood Diseases Hospital, China. The trial plans to enroll 35 participants.