Relapsed or Refractory Plasma Cell NeoplasmsEarly Phase 1CAR19BCMANCT07077330
CAR19BCMA CAR-T Cells for the Treatment of R/R Plasma Cell Neoplasms
A Early Phase 1 study testing CAR19BCMA-T cells in people with Relapsed or Refractory Plasma Cell Neoplasms, run by Chinese PLA General Hospital at 2 sites in China.
Trial summary
This is a single arm study to evaluate the safety and efficacy of CAR19BCMA CAR-T cells in the treatment of relapsed/refractory CD19/BCMA positive plasma cell neoplasms. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed or Refractory Plasma Cell Neoplasms
- What is being tested?
- CAR19BCMA-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- 1 Aug 2025to 1 Aug 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapsed/refractory CD19BCMA positive plasma cell neoplasms must be assured and meet all of the following conditions:
- 1.1 Confirmation for either BCMA or CD19 positivity using immunohistochemistry or flow cytometry.
- 1.2 Patients with multiple myeloma, plasma cell carcinoma, and plasma cell leukemia who have received at least three 3 lines treatment (including anti-CD38 monoclonal antibodies, protease inhibitors, immunosuppressants, etc.) but have failed or experienced relapse.
- 1.3 Patients with system light chain amyloidosis who have received at least 2 lines treatments in the past [anti-CD38 monoclonal antibody, proteasome inhibitor (PI), or immunomodulatory drug (IMiD)], but have failed or experienced relapse.
- Age 18-75 years,
- no gender restrictions;
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- ECOG score ≤ 2 points;
- Expected survival period is not less than 3 months;
- HGB≥60g/L;
- Liver and kidney function and cardiopulmonary function meet the following requirements: (1) Creatinine ≤ 2× ULN; (2)left ventricular ejection fraction≥50%; (3) Oxygen saturation >90%; (4)Total bilirubin ≤1.5×ULN, ALT and AST≤2.5×ULN;
- Participants agreed to use contraception from the time of informed consent until 1 year after CAR-T cell infusion.
Who cannot join
- Severe heart failure with left ventricular ejection fraction <50%;
- A history of severe lung function impairment; Combined with other advanced malignant tumors;
- Complicated with severe infection that could not be effectively controlled;
- Severe autoimmune disease or congenital immune deficiency;
- Active viral hepatitis (defined as positive hepatitis B virus DNA [HBV-DNA] or hepatitis C virus RNA [HCV-RNA] detection, with test results exceeding the lower limit of quantification); Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection;
- History of severe allergy to biological products (including antibiotics);
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- Allogeneic hematopoietic stem cell transplant patients who still have an acute graft-versus-host response (GVHD) one month after discontinuation of immunosuppressants;
- Patients with other serious physical or mental illnesses or laboratory abnormalities that could increase the risk of participating in the study or interfere with the results of the study, and those who were deemed by the investigator to be unsuitable for participation in the study;
- Female patients (those with fertility) are in pregnancy or lactation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
The Four Medical Center of PLA General Hospital, China
Beijing
XiaoHong Li Dr, +86 136 9366 6349, lily.lxh@163.com
The Six Medical Center of PLA General Hospital, China
Beijing
Yi Liu Dr, +86 186 0031 0985, 18600310985@163.com
About this study
Official title: A Clinical Study on the Safety and Efficacy of CAR19-BCMA Dual-target CAR-T Cell Therapy for Relapsed/Refractory Plasma Cell Neoplasms
This is a single arm study to evaluate the safety and efficacy of CAR19BCMA CAR-T cells in the treatment of relapsed/refractory CD19/BCMA positive plasma cell neoplasms.
Read the detailed description
This study is an exploratory clinical trial of a single-arm, open, single-center treatment of CAR19BCMA CAR-T cell. 20 subjects with relapsed or refractory CD19/ BCMA positive positive plasma cell neoplasms will be enrolled and received CAR19BCMA CAR T cells injection therapy, and related data such as adverse reactions and therapeutic effects after medication were followed up. To evaluate its safety and efficacy
- Being tested
- CAR19BCMA-T cells
- Keywords
- CAR-T, plasma cell neoplasms, CD19/BCMA
- Medical subject headings
- Recurrence, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR19BCMA-T cellsOther
CAR19BCMA-T cells Each subject will be infused with single dose of CD19BCMA-CAR-T cells. A classic "3+3" dose escalation will be employed. The low dose is 1×10^6 /kg, the medium dose is 2×10^6 /kg, and the high dose is 3×10^6 /kg.
Drug: fludarabine and cyclophosphamide Drug: Fludarabine Fludarabine will be given at a dose of 30 mg/m2/day intravenously (IV) for 3 days prior to the infusion of CD19BCMA-CAR-T cells. Drug: Cyclophosphamide Cyclophosphamide will be given at a dose of 300 mg
| Study group | Role | What they receive |
|---|---|---|
| This is a single arm treatment of CAR19BCMA CAR-T cell | Experimental | Not described Receives: Other: CAR19BCMA-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
According to the incidence of treatment-related adverse events (AEs) to evaluate the safetyof CAR19BCMA CAR-T cells in the treatment of relapsed/refractory CD19+BCMA+plasma cell neoplasms.
Incidence of treatment-related adverse events (AEs) Description: Number and severity of adverse events graded according to CTCAE v5.0, including cytokine release syndrome (CRS) graded by ASTCT criteria and immune effector cell-associated neurotoxicity syndrome (ICANS) graded by ASBMT criteria
Measured: up to 3 years
According to the determine the Maximal Tolerable Dose(MTD) to evaluate the safety of CAR19BCMA CAR-T cells in the treatment of relapsed/refractory CD19+BCMA+ plasma cell neoplasms.
Measured: MTD will be determined based on DLTs observed during the first 28 days of study treatment
Secondary outcomes (1)
According to the objective response rate (ORR) to evaluate the efficacy of CAR19BCMA CAR-T cells in the treatment of relapsed/refractory CD19+BCMA+ plasma cell neoplasms.
Overall response rate (ORR) Description: Multiple myeloma (plasma cell neoplasms, plasma cell leukemia) refers to the efficacy evaluation criteria in the Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma (revised in 2024),ORR includes strictly defined proportions of complete response (sCR), complete response (CR), very good partial response (VGPR),partial response (PR), and minimal response (MR).
Measured: Within 3 months following infusion of CAR19BCMA CAR-T cells
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Plasma Cell NeoplasmsStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- CAR-T
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunji Gao, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077330
- Sponsor's protocol ID
- 2025-653-01
- Other IDs
- 2025KY072-KS001
- Acronym
- CAR19BCMA
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- 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 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Safety and Efficacy of CAR19-BCMA Dual-target CAR-T Cell Therapy for Relapsed/Refractory Plasma Cell Neoplasms
- ClinicalTrials.gov ID
- NCT07077330
- Acronym / sponsor ID
- CAR19BCMA / 2025-653-01
- Keywords
- CAR-T, plasma cell neoplasms, CD19/BCMA
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 22 Jul 2025 (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 single arm study to evaluate the safety and efficacy of CAR19BCMA CAR-T cells in the treatment of relapsed/refractory CD19/BCMA positive plasma cell neoplasms.
Detailed description
This study is an exploratory clinical trial of a single-arm, open, single-center treatment of CAR19BCMA CAR-T cell. 20 subjects with relapsed or refractory CD19/ BCMA positive positive plasma cell neoplasms will be enrolled and received CAR19BCMA CAR T cells injection therapy, and related data such as adverse reactions and therapeutic effects after medication were followed up. To evaluate its safety and efficacy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- CAR-T
| Arm | Type | Receives |
|---|---|---|
| This is a single arm treatment of CAR19BCMA CAR-T cell | Experimental | Other: CAR19BCMA-T cells |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Relapsed/refractory CD19BCMA positive plasma cell neoplasms must be assured and meet all of the following conditions:
- 1.1 Confirmation for either BCMA or CD19 positivity using immunohistochemistry or flow cytometry.
- 1.2 Patients with multiple myeloma, plasma cell carcinoma, and plasma cell leukemia who have received at least three 3 lines treatment (including anti-CD38 monoclonal antibodies, protease inhibitors, immunosuppressants, etc.) but have failed or experienced relapse.
- 1.3 Patients with system light chain amyloidosis who have received at least 2 lines treatments in the past [anti-CD38 monoclonal antibody, proteasome inhibitor (PI), or immunomodulatory drug (IMiD)], but have failed or experienced relapse.
- Age 18-75 years,
Key exclusion criteria (9 listed)
- Severe heart failure with left ventricular ejection fraction <50%;
- A history of severe lung function impairment; Combined with other advanced malignant tumors;
- Complicated with severe infection that could not be effectively controlled;
- Severe autoimmune disease or congenital immune deficiency;
- Active viral hepatitis (defined as positive hepatitis B virus DNA [HBV-DNA] or hepatitis C virus RNA [HCV-RNA] detection, with test results exceeding the lower limit of quantification); Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection;
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 |
|---|---|---|
| CAR19BCMA-T cellsCAR19BCMA-T cells Each subject will be infused with single dose of CD19BCMA-CAR-T cells. A classic "3+3" dose escalation will be employed. The low dose is 1×10^6 /kg, the medium dose is 2×10^6 /kg, and the high dose is 3×10^6 /kg. Drug: fludarabine and cyclophosphamide Drug: Fludarabine Fludarabine will be given at a dose of 30 mg/m2/day intravenously (IV) for 3 days prior to the infusion of CD19BCMA-CAR-T cells. Drug: Cyclophosphamide Cyclophosphamide will be given at a dose of 300 mg | Other | This is a single arm treatment of CAR19BCMA CAR-T cell |
Primary outcome
According to the incidence of treatment-related adverse events (AEs) to evaluate the safetyof CAR19BCMA CAR-T cells in the treatment of relapsed/refractory CD19+BCMA+plasma cell neoplasms.
Time frame: up to 3 years
Incidence of treatment-related adverse events (AEs) Description: Number and severity of adverse events graded according to CTCAE v5.0, including cytokine release syndrome (CRS) graded by ASTCT criteria and immune effector cell-associated neurotoxicity syndrome (ICANS) graded by ASBMT criteria
According to the determine the Maximal Tolerable Dose(MTD) to evaluate the safety of CAR19BCMA CAR-T cells in the treatment of relapsed/refractory CD19+BCMA+ plasma cell neoplasms.
Time frame: MTD will be determined based on DLTs observed during the first 28 days of study treatment
1 secondary outcome
According to the objective response rate (ORR) to evaluate the efficacy of CAR19BCMA CAR-T cells in the treatment of relapsed/refractory CD19+BCMA+ plasma cell neoplasms.
Time frame: Within 3 months following infusion of CAR19BCMA CAR-T cells
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CAR19BCMA-T cells in people with Relapsed or Refractory Plasma Cell Neoplasms, run by Chinese PLA General Hospital 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 9 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: opening soon, as of the sponsor's last update on 22 Jul 2025. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Liu Dr (+86 186 0031 0985, 18600310985@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
According to the incidence of treatment-related adverse events (AEs) to evaluate the safetyof CAR19BCMA CAR-T cells in the treatment of relapsed/refractory CD19+BCMA+plasma cell neoplasms. (time frame: up to 3 years). 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?
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 Jul 2025.