Relapsed/Refractory Multiple MyelomaPhase 1NCT05376345
BCMA-targeted LCAR-BCDR Cells in Patients With Relapsed/Refractory Multiple Myeloma
A Phase 1 study testing LCAR-BCDR cells product in people with Relapsed/Refractory Multiple Myeloma, run by Shanghai Changzheng Hospital at 6 sites in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Multiple Myeloma
- What is being tested?
- LCAR-BCDR cells product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 6 sitesChina
- Study dates
- 1 Sep 2022to 27 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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;
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Beijing Boren Hospital
Beijing, Beijing Municipality
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
Shanghai Changzheng Hospital
Shanghai
Shanghai Fourth People's Hospital Affiliated to Tongji University
Shanghai
Institute of Hematology & Blood Diseases Hospital
Tianjin
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of BCMA-targeted LCAR-BCDR Cells Product in Patients With Relapsed/Refractory Multiple Myeloma
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.
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Being tested
- LCAR-BCDR cells product
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCAR-BCDR cells productBiological
Before treatment with LCAR-BCDR cells, subjects will receive a conditioning regimen
| Study group | Role | What they receive |
|---|---|---|
| LCAR-BCDR cells product | Experimental | Each subject will receive LCAR-BCDR cells Receives: Biological: LCAR-BCDR cells product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Minimum 2 years after LCAR-BCDR infusion (Day 1)
Recommended Phase 2 dose (RP2D) finding
RP2D established through ATD+BOIN design
Measured: 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
Measured: 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
Measured: Minimum 2 years after LCAR-BCDR infusion (Day 1)
Secondary outcomes (4)
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.
Measured: Minimum 2 years after LCAR-BCDR infusion (Day 1)
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
Measured: Minimum 2 years after LCAR-BCDR infusion (Day 1)
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
Measured: Minimum 2 years after LCAR-BCDR infusion (Day 1)
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
Measured: Minimum 2 years after LCAR-BCDR infusion (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start1 Sep 2022
- Primary completion27 May 2025
- Study completion27 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Weijun Fu, Shanghai Changzheng Hospital
- Investigators
- Weijun Fu, PhD, Principal investigator, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05376345
- Sponsor's protocol ID
- BM2L202103
- Status last verified
- Sep 2026
- First submitted
- 12 May 2022
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of BCMA-targeted LCAR-BCDR Cells Product in Patients With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05376345
- Acronym / sponsor ID
- BM2L202103
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- 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
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 27 May 2025 (actual)
- Study completion
- 27 May 2025 (actual)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LCAR-BCDR cells product | Experimental | Biological: LCAR-BCDR cells productEach subject will receive LCAR-BCDR cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LCAR-BCDR cells productBefore treatment with LCAR-BCDR cells, subjects will receive a conditioning regimen | Biological | LCAR-BCDR cells product |
Primary outcome
Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
Time frame: Minimum 2 years after LCAR-BCDR infusion (Day 1)
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.
Recommended Phase 2 dose (RP2D) finding
Time frame: 30 days after LCAR-BCDR infusion (Day 1)
RP2D established through ATD+BOIN design
CAR positive T cells in peripheral blood and bone marrow
Time frame: Minimum 2 years after LCAR-BCDR infusion (Day 1)
CAR positive T cells in peripheral blood and bone marrow after LCAR-BCDR infusion
CAR transgene levels in peripheral blood and bone marrow
Time frame: Minimum 2 years after LCAR-BCDR infusion (Day 1)
CAR transgene levels in peripheral blood and bone marrow after LCAR-BCDR infusion
4 secondary outcomes
Overall Response Rate (ORR)
Time frame: Minimum 2 years after LCAR-BCDR infusion (Day 1)
Progression-free survival (PFS)
Time frame: Minimum 2 years after LCAR-BCDR infusion (Day 1)
Overall Survival (OS)
Time frame: Minimum 2 years after LCAR-BCDR infusion (Day 1)
Incidence of anti-LCAR-BCDR antibody
Time frame: Minimum 2 years after LCAR-BCDR infusion (Day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weijun Fu, PhD principal investigator
Shanghai Changzheng Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LCAR-BCDR cells product in people with Relapsed/Refractory Multiple Myeloma, run by Shanghai Changzheng Hospital at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, severity, and type of treatment-emergent adverse events (TEAEs) (time frame: Minimum 2 years after LCAR-BCDR infusion (Day 1)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.