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

Nanjing Medical University

Status

Not yet enrolling

Conditions

Relapsed/Refractory Multiple Myeloma

Treatments

Biological: LCAR-M61S cells preparation

Biological: LCAR-M61D cells preparation

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06472479

LB2401-0001

Details and patient eligibility

About

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.

Full description

This study was a prospective, two-cohort, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of LCAR-M61S and LCAR-M61D in patients with relapsed/refractory multiple myeloma. All subjects who meet the eligibility criteria will receive intravenous injection of LCAR-M61S or LCAR-M61D cell injection. The study will include the following sequential phases: screening, apheresis, pre-treatment (lymphodepleting chemotherapy), treatment, and follow-up.

Enrollment

66 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 and/or CD19 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.