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NCT06472479Not yet recruiting

LCAR-M61S and LCAR-M61D in Treatment of Relapsed/Refractory Multiple Myeloma

A Clinical Study to Evaluate the Safety, Tolerance and Efficacy of LCAR-M61S and LCAR-M61D Cell Preparations in Patients With Relapsed/Refractory Multiple Myeloma

Source: ClinicalTrials.gov · Last updated 28 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

A prospective, two-cohort, open-label dose-exploration and expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of LCAR-M61S and LCAR-M61D in patients with relapsed/refractory multiple myeloma.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
66 (estimated)
First submitted
6 Jun 2024
Start date
1 Jul 2024
Primary completion date
22 Aug 2028
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
NCT number
NCT06472479

What you commit to

  • Study type: Interventional
  • Planned participants: 66
  • From 1 Jul 2024 to the primary completion date, 22 Aug 2028
  • 4 sites in 1 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 and/or CD19 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

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beijing GoBroad Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
Anhui Cancer Hospital
Coordinator of this site? Confirm its status
HefeiChinaUnknown status
Jiangsu Province Hospital
Coordinator of this site? Confirm its status
NanjingChinaUnknown status
Henan Cancer Hospital
Coordinator of this site? Confirm its status
ZhengzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.