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

NCT05376345 | Terminated Phase 1

• 1 other identifier: BM2L202103
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 6

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

Outcome Measures

Primary Outcomes (4)

• Incidence, severity, and type of treatment-emergent adverse events (TEAEs)

  An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment.

  Minimum 2 years after LCAR-BCDR infusion (Day 1)

• Recommended Phase 2 dose (RP2D) finding

  RP2D established through ATD+BOIN design

  30 days after LCAR-BCDR infusion (Day 1)

• CAR positive T cells in peripheral blood and bone marrow

  CAR positive T cells in peripheral blood and bone marrow after LCAR-BCDR infusion

  Minimum 2 years after LCAR-BCDR infusion (Day 1)

• CAR transgene levels in peripheral blood and bone marrow

  CAR transgene levels in peripheral blood and bone marrow after LCAR-BCDR infusion

  Minimum 2 years after LCAR-BCDR infusion (Day 1)

Secondary Outcomes (4)

• Overall Response Rate (ORR)

  Minimum 2 years after LCAR-BCDR infusion (Day 1)

• Progression-free survival (PFS)

  Minimum 2 years after LCAR-BCDR infusion (Day 1)

• Overall Survival (OS)

  Minimum 2 years after LCAR-BCDR infusion (Day 1)

• Incidence of anti-LCAR-BCDR antibody

  Minimum 2 years after LCAR-BCDR infusion (Day 1)

Study Arms (1)

LCAR-BCDR cells product

EXPERIMENTAL

Each subject will receive LCAR-BCDR cells

Biological: LCAR-BCDR cells product

Interventions

LCAR-BCDR cells product BIOLOGICAL

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

LCAR-BCDR cells product

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Subjects ≥ 18 years of age.
• Documented initial diagnosis of MM according to IMWG diagnostic criteria.
• Presence of measurable disease at screening.
• Received a PI and an IMiD (except thalidomide).
• 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.
• Expected survival ≥ 3 months.
• Clinical laboratory values meet screening visit criteria
• 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;

You may not qualify if:

• No response to prior BCMA-targeted CAR-T therapy (except in subjects who relapsed after CR to prior CAR-T treatment).
• Prior treatment with any antibody targeting BCMA.
• Diagnosed or pretreated for an invasive malignancy other than multiple myeloma.
• Prior anti-tumor treatment (before pretreatment) with insufficient washout period.
• Known active, or prior history of central nervous system (CNS) involvement, or clinical signs of membrane/spinal membrane involvement of multiple myeloma.
• 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.
• Serious underlying medical conditions
• Male subjects who have a birth plan during the study period or within 1 year after the study treatment.
• Female subjects who are pregnant, breast-feeding, or plan to become pregnant during the study period or within 1 year after the study treatment.
• The investigator considered that the subjects were not suitable for any conditions of participation in the study.

Sponsors & Collaborators

• Weijun Fu: lead
• Nanjing Legend Biotech Co.: collaborator

Study Sites (6)

Beijing Gobroad Boren Hospital

Beijing, Beijing Municipality, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Location

Shanghai Changzheng Hospital

Shanghai, China

Location

Shanghai Fourth People's Hospital Affiliated to Tongji University

Shanghai, China

Location

Institute of Hematology & Blood Diseases Hospital

Tianjin, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 17, 2022
• Study Start: September 1, 2022
• Primary Completion: May 27, 2025
• Study Completion: May 27, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)