RecruitingNot ApplicableNCT07100067

LCAR-F33S in Treatment of Relapsed/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.


Sponsor

Nanjing Legend Biotech Co.

Enrollment

35 participants

Start Date

Sep 16, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new CAR-T cell therapy called LCAR-F33S for people with multiple myeloma (a blood cancer) that has come back or stopped responding to at least three prior lines of treatment, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody. LCAR-F33S uses engineered immune cells to attack and kill myeloma cells. **You may be eligible if...** - You are 18 or older - You have multiple myeloma with measurable disease - You have received at least 3 prior lines of treatment (including all three major drug classes) - Your disease is still active with measurable markers - You are well enough to participate (ECOG 0–2) - Your expected survival is at least 3 months **You may NOT be eligible if...** - You have previously received a therapy targeting the FcRH5 protein - You have plasma cell leukemia, Waldenstrom's disease, POEMS syndrome, or AL amyloidosis - You are positive for HIV, hepatitis B, or hepatitis C - You have a life-threatening allergy to CAR-T cell ingredients (including DMSO) - You are pregnant, breastfeeding, or planning pregnancy within 1 year of treatment - You are enrolled in another clinical study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALLCAR- F33S cells intravenous infusion

Prior to infusion of the LCAR- F33S cell, Subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.


Locations(4)

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

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NCT07100067


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