Multiple MyelomaNCT04447573
Immunotherapy With BCMA CAR-T Cells in Treating Patients With Relapsed or Refractory Multiple Myeloma
A study testing BCMA CAR-T in people with Multiple Myeloma, run by Hebei Senlang Biotechnology Inc., Ltd. at 2 sites in China.
Trial summary
This study is aimed to evaluate the safety, feasibility and efficacy of BCMA CAR-T in the treatment of relapsed or refractory multiple myeloma Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- BCMA CAR-T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- 30 Jun 2020to 30 Dec 2022
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects voluntarily participated in the study and signed the informed consent form by themselves or their legal guardian;
- According to the international standard for multiple myeloma (IMWG 2014);
- Diagnosed as relapsed or refractory multiple myeloma. Relapsed and refractory were defined as follow. Relapsed: patients had received for at least 3 drugs with different mechanisms of action (including protease inhibitors and immunomodulators) and disease progression within 60 days of the most recent treatment. Refractory was defined as: disease progression occurred during the recent treatment, or disease progression occurred within 60 days after treatment;
- The expression of BCMA in myeloma cells was reported as positive by flow cytometry or immunohistochemistry;
- No antibody drug was administered within last 2 weeks before cell therapy;
- ECOG Scores: 0~1
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- Echocardiography showed normal diastolic function, left ventricular ejection fraction (LVEF) ≥ 50%, no serious arrhythmia;
- The subjects had no pulmonary infection, normal pulmonary function, and indoor air oxygen saturation ≥ 92%;
- There was no contraindication for peripheral blood sampling;
- The estimated survival time was more than 12 weeks;
- The urine pregnancy test of female subjects of childbearing age should be negative and not in lactation; the female or male subjects of childbearing age should take effective contraceptive measures during the whole research process.
Who cannot join
- Have a history of allergy to any component of cell products;
- There are clinically significant cardiovascular diseases, such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or any grade 3 (moderate) or grade 4 (severe) heart disease with cardiac function (according to the functional classification method of the New York Heart AssociationNYHA) with a history of myocardial infarction, angioplasty or stent implantation, unstable angina or other clinically significant heart disease within 12 months before admission;
- who has suffered from brain injury, consciousness disorder, epilepsy, more serious cerebral ischemia or cerebral hemorrhage disease;
- Patients who need urgent treatment due to tumor progression or spinal cord compression;
- The investigator determines that there are serious complications or diseases that will increase the risk of the subject or affect the study, including but not limited to, for example, cirrhosis, recent major trauma, etc;
- After allogeneic hematopoietic stem cell transplantation;
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- Patients with autoimmune diseases, immunodeficiency or other diseases requiring immunosuppressive （excluding glucocorticoid）therapy;
- There was uncontrolled active infection;
- There were live vaccinations within 4 weeks before admission;
- Active hepatitis (positive for HBVDNA or HCVRNA), syphilis and other acquired and congenital immunodeficiency diseases, including but not limited to those with HIV infection;
- Subjects had a history of alcohol, drug or mental illness;
- The researchers believe that there are other conditions that subjects are not suitable to participate in this study.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
BeiJing Ludaopei Hospital
Beijing, Yizhuang, 100000
Peihua Lu, PhD&MD, 008618611636172, peihua_lu@126.com
Peihua Lu, PhD&MD
- Recruiting
He bei Yan da Lu dao pei Hospital
Yanda, Hebei
Peihua Lu, MD/PhD
About this study
This study is aimed to evaluate the safety, feasibility and efficacy of BCMA CAR-T in the treatment of relapsed or refractory multiple myeloma
Read the detailed description
This is a study to evaluate the safety, feasibility and efficacy of BCMA CAR-T in the treatment of relapsed or refractory multiple myeloma.
The Main research objectives:
To evaluate the safety and efficacy of BCMA CAR-T in patients with relapsed or refractory multiple myeloma
The Secondary research objectives:
To investigate the cytokinetic characteristics of BCMA CAR-T in patients with relapsed or refractory multiple myeloma.
- Conditions
- Multiple Myeloma
- Being tested
- BCMA CAR-T
- Keywords
- BCMA，MM
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCMA CAR-TBiological
Biological: BCMA CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis;
| Study group | Role | What they receive |
|---|---|---|
| BCMA CAR-T cells | Experimental | Patients will be treated with BCMA CAR-T cells Receives: Biological: BCMA CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence and severity of adverse events
To evaluate the possible adverse events occurred within first one month after BCMA CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
Measured: First month post CAR-T cells infusion
Efficacy: Overall Remission Rate (ORR)
Overall Remission Rate (ORR) including partial remission and complete
Measured: 3 months post CAR-T cells infusion
Secondary outcomes (4)
Efficacy:duration of response (DOR)
duration of response (DOR)
Measured: 24 months post CAR-T cells infusion
Efficacy: progression-free survival (PFS)
progression-free survival (PFS) time
Measured: 24 months post CAR-T cells infusion
CAR-T proliferation
the copy number of BCMA CAR- T cells in the genomes of PBMC by qPCR method and percentage of BCMA CAR- T cells measured by flow cytometry method
Measured: 3 months post CAR-T cells infusion
Cytokine release
Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method
Measured: First month post CAR-T cells infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start30 Jun 2020
- Primary completion30 Aug 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Lu Daopei Hospital, Hebei Yanda Ludaopei Hospital
- Responsible party
- Sponsor
- Investigators
- Peihua Lu, PhD&MD, Principal investigator, Beijing Lu Daopei Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04447573
- Sponsor's protocol ID
- BCMA CAR-T
- Status last verified
- Aug 2020
- First submitted
- 22 Jun 2020
- Last updated
- 29 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang XG, Wang L, Yang J, Hu XN, Wang H, Zhang LN, Zhou X, Liu Y, Wang Q, Lu PH. Efficacy and safety of BCMA nanobody CAR T-cell therapy in relapsed or refractory plasma cell myeloma. Blood Adv. 2025 Sep 23;9(18):4543-4552. doi: 10.1182/bloodadvances.2025016322.
PubMed 40569697
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunotherapy With BCMA CAR-T Cells in Treating Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04447573
- Acronym / sponsor ID
- BCMA CAR-T
- Conditions
- Multiple Myeloma
- Keywords
- BCMA，MM
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Beijing Lu Daopei Hospital, Hebei Yanda Ludaopei Hospital
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 25 Jun 2020 (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 study is aimed to evaluate the safety, feasibility and efficacy of BCMA CAR-T in the treatment of relapsed or refractory multiple myeloma
Detailed description
This is a study to evaluate the safety, feasibility and efficacy of BCMA CAR-T in the treatment of relapsed or refractory multiple myeloma.
The Main research objectives:
To evaluate the safety and efficacy of BCMA CAR-T in patients with relapsed or refractory multiple myeloma
The Secondary research objectives:
To investigate the cytokinetic characteristics of BCMA CAR-T in patients with relapsed or refractory multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BCMA CAR-T cells | Experimental | Biological: BCMA CAR-TPatients will be treated with BCMA CAR-T cells |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- The subjects voluntarily participated in the study and signed the informed consent form by themselves or their legal guardian;
- According to the international standard for multiple myeloma (IMWG 2014);
- Diagnosed as relapsed or refractory multiple myeloma. Relapsed and refractory were defined as follow. Relapsed: patients had received for at least 3 drugs with different mechanisms of action (including protease inhibitors and immunomodulators) and disease progression within 60 days of the most recent treatment. Refractory was defined as: disease progression occurred during the recent treatment, or disease progression occurred within 60 days after treatment;
- The expression of BCMA in myeloma cells was reported as positive by flow cytometry or immunohistochemistry;
- No antibody drug was administered within last 2 weeks before cell therapy;
Key exclusion criteria (12 listed)
- Have a history of allergy to any component of cell products;
- There are clinically significant cardiovascular diseases, such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or any grade 3 (moderate) or grade 4 (severe) heart disease with cardiac function (according to the functional classification method of the New York Heart AssociationNYHA) with a history of myocardial infarction, angioplasty or stent implantation, unstable angina or other clinically significant heart disease within 12 months before admission;
- who has suffered from brain injury, consciousness disorder, epilepsy, more serious cerebral ischemia or cerebral hemorrhage disease;
- Patients who need urgent treatment due to tumor progression or spinal cord compression;
- The investigator determines that there are serious complications or diseases that will increase the risk of the subject or affect the study, including but not limited to, for example, cirrhosis, recent major trauma, etc;
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 |
|---|---|---|
| BCMA CAR-TBiological: BCMA CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis; | Biological | BCMA CAR-T cells |
Primary outcome
Safety: Incidence and severity of adverse events
Time frame: First month post CAR-T cells infusion
To evaluate the possible adverse events occurred within first one month after BCMA CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
Efficacy: Overall Remission Rate (ORR)
Time frame: 3 months post CAR-T cells infusion
Overall Remission Rate (ORR) including partial remission and complete
4 secondary outcomes
Efficacy:duration of response (DOR)
Time frame: 24 months post CAR-T cells infusion
Efficacy: progression-free survival (PFS)
Time frame: 24 months post CAR-T cells infusion
CAR-T proliferation
Time frame: 3 months post CAR-T cells infusion
Cytokine release
Time frame: First month post CAR-T cells infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Derived from this study: PubMed 40569697Zhang XG, Wang L, Yang J, Hu XN, Wang H, Zhang LN, Zhou X, Liu Y, Wang Q, Lu PH. Efficacy and safety of BCMA nanobody CAR T-cell therapy in relapsed or refractory plasma cell myeloma. Blood Adv. 2025 Sep 23;9(18):4543-4552. doi: 10.1182/bloodadvances.2025016322.
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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.
Peihua Lu, PhD&MD principal investigator
Beijing Lu Daopei Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCMA CAR-T in people with Multiple Myeloma, run by Hebei Senlang Biotechnology Inc., Ltd. at 2 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 11 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peihua Lu, PhD&MD (008618611636172, peihua_lu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Incidence and severity of adverse events (time frame: First month post CAR-T cells infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04447573, which also lists 1 linked publication.
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 29 Sep 2020; AzTrials last refreshed its copy on 7 Nov 2026.