LCAR-M61SQ in Treatment of Relapsed/Refractory Multiple Myeloma

Launched by FIRST AFFILIATED HOSPITAL OF WENZHOU MEDICAL UNIVERSITY · Mar 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called LCAR-M61SQ for people with relapsed or refractory multiple myeloma, which means their cancer has come back or hasn’t responded to previous treatments. The trial aims to find out how safe and effective LCAR-M61SQ is, as well as how it behaves in the body. It is not currently recruiting participants, but once it starts, it will welcome adults aged 18 and older, who have had at least three prior treatments for multiple myeloma and have measurable disease.

Eligible participants will undergo tests to ensure they are in good health and can tolerate the treatment. Throughout the trial, participants will be monitored closely for any side effects and how their cancer responds to the treatment. It's important to note that individuals with certain medical conditions or who have received specific previous therapies will not be able to participate. Overall, this trial represents a potential new option for patients looking for alternative treatments for their multiple myeloma.

Gender

ALL

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 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 GPRC5D targets;
• • Prior antineoplastic therapy and meet exclusion criteria (before apheresis);
• • Subjects had 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.