NCT06888752Not yet recruiting
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.
Source: ClinicalTrials.gov · Last updated 21 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 35 (estimated)
- First submitted
- 17 Mar 2025
- Start date
- 20 Mar 2025
- Primary completion date
- 30 Jun 2030
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical University
- Diseases
- Multiple myeloma
- NCT number
- NCT06888752
What you commit to
- Study type: Interventional
- Planned participants: 35
- From 20 Mar 2025 to the primary completion date, 30 Jun 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received previous therapy targeting GPRC5D targets;
- Prior antineoplastic therapy and meet exclusion criteria (before apheresis);
- Female subjects who were pregnant, breastfeeding, or planning to become pregnant while participating in this study or within 1 year of receiving study treatment.
Other illness
- 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;
Other
- Also enrolled in other clinical studies.
Who the study is looking for
- 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;
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.