BCMA-targeted LCAR-BCDR Cells in Patients With Relapsed/Refractory Multiple Myeloma

NCT ID: NCT05376345

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2025-05-27

Brief Summary

This is a prospective, single-arm, open-label, dose-finding and dose-expansion study that evaluates the safety, tolerability, PK, and anti-tumor efficacy of LCAR-BCDR cell preparations in relapsed/refractory multiple myeloma subjects who received adequate standard therapy.

Conditions

Relapsed/Refractory Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LCAR-BCDR cells product

Each subject will receive LCAR-BCDR cells

Group Type: EXPERIMENTAL

LCAR-BCDR cells product

Intervention Type: BIOLOGICAL

Before treatment with LCAR-BCDR cells, subjects will receive a conditioning regimen

Interventions

LCAR-BCDR cells product

Before treatment with LCAR-BCDR cells, subjects will receive a conditioning regimen

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. The subject voluntarily participates in the clinical study; Fully understand and be Informed of the study and sign the Informed consent (Informed Consent Form, ICF); Willing to follow and able to complete all test procedures; Informed consent must be obtained before initiating any tests or procedures related to the study that are not part of the standard treatment of the subject's disease;

2. Subjects ≥ 18 years of age.

3. Documented initial diagnosis of MM according to IMWG diagnostic criteria.

4. Presence of measurable disease at screening.

5. Received a PI and an IMiD (except thalidomide).

6. Received at least 3 prior lines of therapy for multiple myeloma, undergone at least 1 complete cycle of treatment for each line, unless progressive disease (PD) was documented by IMWG criteria as the best response to the regimen. Also, subjects refractory or intolerant to any PI and any IMiD in their previous treatment afterwards are eligible.

7. Expected survival ≥ 3 months.

8. Clinical laboratory values meet screening visit criteria

9. Fertile women must be negative using a highly sensitive serum pregnancy test (β human chorionic gonadotropin [β -HCG]) at screening time and before initial treatment with cyclophosphamide and fludarabine;

Exclusion Criteria

1. No response to prior BCMA-targeted CAR-T therapy (except in subjects who relapsed after CR to prior CAR-T treatment).

2. Prior treatment with any antibody targeting BCMA.

3. Diagnosed or pretreated for an invasive malignancy other than multiple myeloma.

4. Prior anti-tumor treatment (before pretreatment) with insufficient washout period.

5. Known active, or prior history of central nervous system (CNS) involvement, or clinical signs of membrane/spinal membrane involvement of multiple myeloma.

6. Positive of any hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), human immunodeficiency virus antibody (HIV-Ab) at the time of screening.

7. Serious underlying medical conditions

8. Male subjects who have a birth plan during the study period or within 1 year after the study treatment.

9. Female subjects who are pregnant, breast-feeding, or plan to become pregnant during the study period or within 1 year after the study treatment.

10. The investigator considered that the subjects were not suitable for any conditions of participation in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Legend Biotech Co.

INDUSTRY

Sponsor Role: collaborator

Weijun Fu

OTHER

Sponsor Role: lead

Responsible Party

Weijun Fu

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Beijing Gobroad Boren Hospital

Beijing, Beijing Municipality, China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Shanghai Changzheng Hospital

Shanghai, , China

Shanghai Fourth People's Hospital Affiliated to Tongji University

Shanghai, , China

Institute of Hematology & Blood Diseases Hospital

Tianjin, , China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, , China

Countries

China

Other Identifiers

BM2L202103

Identifier Type: -

Identifier Source: org_study_id