Status:
NOT_YET_RECRUITING
LCAR-M61SQ in Treatment of Relapsed/Refractory Multiple Myeloma
Lead Sponsor:
First Affiliated Hospital of Wenzhou Medical University
Collaborating Sponsors:
Beijing Boren Hospital
First People's Hospital of Hangzhou
Conditions:
Relapsed/Refractory Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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/re...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2030
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06888752
Start Date
March 20 2025
End Date
December 30 2030
Last Update
March 21 2025
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