NCT07100067

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Nanjing Legend Biotech Co. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This study is a prospective, single-arm, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of LCAR-F33S in patients with relapsed/refractory multiple myeloma. All subjects who meet the eligibility criteria will receive intravenous injection of LCAR-F33S cell injection. The study will include the following sequential phases: screening, apheresis, pre-treatment (lymphodepleting chemotherapy), treatment, and follow-up.

Conditions

• Relapsed/Refractory Multiple Myeloma(MM)

Interventions

Type	Name	Description
BIOLOGICAL	LCAR- F33S cells intravenous infusion	Prior to infusion of the LCAR- F33S cell, Subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.

Timeline

• Start date: 2025-09-16
• Primary completion: 2028-02-20
• Completion: 2029-11-20
• First posted: 2025-08-03
• Last updated: 2025-12-29

Locations

4 sites across 1 country: China