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• A Single-center Exploratory Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of a BCMA-targeted Universal LCAR-BCX Cells in Patients With Relapsed/Refractory Multiple Myeloma

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ClinicalTrials.gov ID

NCT06472479

Lead Sponsor

The First Affiliated Hospital with Nanjing Medical UniversityOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

66Estimated

Last Update Posted

Jun 28, 2024Actual

Start Date

Jul 1, 2024Estimated

Primary Completion Date

Aug 22, 2028Estimated

Completion Date

Oct 12, 2029Estimated

Official Title

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

Brief Summary

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.

Detailed 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.

• Relapsed/Refractory Multiple Myeloma

• LCAR-M61S cells preparation
• LCAR-M61D cells preparation

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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 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.

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

The First Affiliated Hospital with Nanjing Medical UniversityOTHER

Collaborators

Nanjing Legend Biotech Co.INDUSTRY

weixudong63@126.com13837169301

chenljb@126.com15850521836

huk@gobroadhealthcare.com15010390336