CClinicalTrials.gg
Sign In
CompletedNCT05376345Updated Sep 22, 2026

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

A Phase 1 interventional study of LCAR-BCDR cells product in Relapsed/Refractory Multiple Myeloma, sponsored by Shanghai Changzheng Hospital. Completed at 6 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Shanghai Changzheng Hospital · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

The research plan stipulates that "four dose groups will be conducted, namely 30×10\^6, 100×10\^6, 200×10\^6, and 400×10\^6". The research team held a SET meeting and decided to increase the dose escalation to 600×10\^6 and 800×10\^6, and obtained ethical approval from all sites.

02

Conditions studied

  • Relapsed/Refractory Multiple Myeloma

Browse trials for

03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 24 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Shanghai Changzheng Hospital is the lead sponsor of 125 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    LCAR-BCDR cells product

    Each subject will receive LCAR-BCDR cells

    Biological: LCAR-BCDR cells product

Interventions

  • BiologicalLCAR-BCDR cells product

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

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. Recommended Phase 2 dose (RP2D) finding

    RP2D established through ATD+BOIN design

    Time frame: 30 days after LCAR-BCDR infusion (Day 1)

  3. CAR positive T cells in peripheral blood and bone marrow

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

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

  4. CAR transgene levels in peripheral blood and bone marrow

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

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

Secondary outcomes

  1. Overall Response Rate (ORR)

    The ORR is defined as the percentage of participants who achieve partial response (PR) or better according to international myeloma working group (IMWG) criteria.

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

  2. Progression-free survival (PFS)

    Progression Free Survival (PFS) is defined as the time from the date of first infusion of the LCAR-BCDR to the first documented disease progression (according to IMWG criteria) or death (due to any cause), whichever occurs first

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

  3. Overall Survival (OS)

    Overall Survival (OS) is defined as the time from the date of first infusion of LCAR-AIO to death of the subject

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

  4. Incidence of anti-LCAR-BCDR antibody

    Venous blood samples will be collected to measure LCAR-BCDR positive cell concentrations and the transgenic level of LCAR-BCDR, at the time points when anti-LCAR-BCDR antibody serum samples are evaluated

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

07

Study locations

6 sites
  • Beijing 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
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05376345
Lead sponsor
Shanghai Changzheng Hospital
Collaborators
Nanjing Legend Biotech Co., First Affiliated Hospital of Wenzhou Medical University, Beijing Boren Hospital, Zhejiang Provincial People's Hospital, Shanghai Fourth People's Hospital Tongji University, Institute of Hematology & Blood Diseases Hospital, China
Responsible party
Weijun Fu (Shanghai Changzheng Hospital, Shanghai Changzheng Hospital) — Principal investigator
First posted
May 17, 2022
Start date
Sep 1, 2022
Primary completion
May 27, 2025
Completion
May 27, 2025
Last update
Sep 22, 2026

Study contacts

Weijun Fu, PhD
principal investigator · Shanghai Changzheng Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Multiple Myeloma→

Other studies from this sponsor

Shanghai Changzheng Hospital

Start the discussion