NCT06888752

LCAR-M61SQ in Treatment of Relapsed/Refractory Multiple Myeloma

A Clinical Study to Evaluate the Safety, Tolerance and Efficacy of LCAR-M61SQ Cell in Patients with Relapsed/Refractory Multiple Myeloma.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: First Affiliated Hospital of Wenzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, open-label dose-exploration and expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of LCAR-M61SQ in patients with relapsed/refractory multiple myeloma.

Detailed description

This study is a prospective, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of LCAR-M61SQ in patients with relapsed/refractory multiple myeloma. All subjects who meet the eligibility criteria will receive intravenous injection of LCAR-M61SQ 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

Interventions

Type	Name	Description
BIOLOGICAL	Cell injection	LCAR-M61SQ cells intravenous infusion; Prior to infusion of the LCAR-M61SQ cell, Subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.

Timeline

• Start date: 2025-03-20
• Primary completion: 2030-06-30
• Completion: 2030-12-30
• First posted: 2025-03-21
• Last updated: 2025-03-21