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Search / Trial NCT06888752

LCAR-M61SQ in Treatment of Relapsed/Refractory Multiple Myeloma

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

Trial Information

Current as of April 23, 2025

Not yet recruiting

Keywords

Multiple Myeloma Relapsed/Refractory Multiple Myeloma

ClinConnect Summary

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.

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.

About First Affiliated Hospital Of Wenzhou Medical University

The First Affiliated Hospital of Wenzhou Medical University is a leading clinical institution dedicated to advancing healthcare through innovative research and comprehensive patient care. As a prominent teaching hospital, it integrates clinical practice with education and research, fostering a collaborative environment for healthcare professionals and researchers. The hospital is committed to conducting high-quality clinical trials that adhere to rigorous ethical standards, aiming to enhance medical knowledge and improve treatment outcomes. With state-of-the-art facilities and a multidisciplinary team of experts, the First Affiliated Hospital plays a pivotal role in the development of new therapies and the translation of scientific discoveries into clinical practice.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported