Relapsed or Refractory Plasma Cell NeoplasmsEarly Phase 1NCT06986434
CAR19BCMA CAR-T Cells for the Treatment of R/R Plasma Cell Neoplasms and Lymphomas/Leukemias With Plasmacytic Differentiation
A Early Phase 1 study testing CAR19BCMA-T cells and fludarabine and cyclophosphamide in people with Relapsed or Refractory Plasma Cell Neoplasms and Lymphomas/Leukemias With Plasmacytic Differentiation, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site 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 and lymphomas/leukemias with plasmacytic differentiation. 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, Lymphomas/Leukemias With Plasmacytic Differentiation
- What is being tested?
- CAR19BCMA-T cells and fludarabine and cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2026to 25 Aug 2028
- 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 and lymphomas/leukemias with plasmacytic differentiation must be assured and meet all of the following conditions:
- Confirmation for either BCMA or CD19 positivity using immunohistochemistry or flow cytometry
- Patients with multiple myeloma, plasma cell carcinoma, plasma cell leukemia and lymphomas/leukemias with plasmacytic differentiation who have received at least three 3 lines treatment (including anti-CD38 monoclonal antibodies, protease inhibitors, immunosuppressants, etc.) but have failed or experienced relapse
- 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 18-80 years, no gender restrictions
- ECOG score ≤ 2 points
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- Expected survival period is not less than 3 months
- HGB≥60g/L
- Liver function and cardiopulmonary function meet the following requirements:
- left ventricular ejection fraction≥50%
- Oxygen saturation >90%
- 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 hepatitis (hepatitis B virus DNA [HBV-DNA] or hepatitis C virus RNA [HCV-RNA] test results above the lower limit of detection)
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- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection
- History of severe allergy to biological products (including antibiotics)
- 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
the Fifth Medical Center of Chinese People's Liberation Army General Hospital
Beijing
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 and Lymphomas/Leukemias With Plasmacytic Differentiation
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 and lymphomas/leukemias with plasmacytic differentiation.
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 and lymphomas/leukemias with plasmacytic differentiation 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.
- Conditions
- Relapsed or Refractory Plasma Cell Neoplasms, Lymphomas/Leukemias With Plasmacytic Differentiation
- Being tested
- CAR19BCMA-T cells, fludarabine and cyclophosphamide
- Keywords
- CAR-T, plasma cell neoplasms, CD19/BCMA, lymphomas/leukemias with plasmacytic differentiation
- Medical subject headings
- Recurrence, Neoplasms, Plasma Cell, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR19BCMA-T cellsGenetic
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.
fludarabine and cyclophosphamideDrug
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/m2/day intravenously (IV) for 3 days prior to the infusion of CD19BCMA-CAR-T cells.
| Study group | Role | What they receive |
|---|---|---|
| This is a single arm treatment of CAR19BCMA CAR-T cell | Experimental | Experimental: CAR19BCMA-T cells Therapy Investigational product: CAR19BCMA-T cells Route of administration: Intravenous injection Lymphodepleting chemotherapy regimen: A combination of fludarabine and cyclophosphamide will be administered prior to the infusion of CD19BCMA-CAR-T cells. Receives: Genetic: CAR19BCMA-T cells; Drug: fludarabine and cyclophosphamide |
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 and lymphomas/leukemias with plasmacytic differentiation.
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 and lymphomas/leukemias with plasmacytic differentiation.
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 and lymphomas/leukemias with plasmacytic differentiation.
Overall response rate (ORR) Description: 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 posted23 May 2025
- Study start2 Apr 2026 (estimated)
- Primary completion22 May 2027 (estimated)
- Study completion25 Aug 2028 (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.
- 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
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06986434
- Sponsor's protocol ID
- CAR19BCMA-XYBYXB
- Status last verified
- Apr 2026
- First submitted
- 15 May 2025
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Apr 2026. 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 and Lymphomas/Leukemias With Plasmacytic Differentiation
- ClinicalTrials.gov ID
- NCT06986434
- Acronym / sponsor ID
- CAR19BCMA-XYBYXB
- Conditions
- Relapsed or Refractory Plasma Cell Neoplasms, Lymphomas/Leukemias With Plasmacytic Differentiation
- Keywords
- CAR-T, plasma cell neoplasms, CD19/BCMA, lymphomas/leukemias with plasmacytic differentiation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical SciencesUniversity, hospital or other
- Study start
- 2 Apr 2026 (estimated)
- Primary completion
- 22 May 2027 (estimated)
- Study completion
- 25 Aug 2028 (estimated)
- First posted
- 23 May 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 and lymphomas/leukemias with plasmacytic differentiation.
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 and lymphomas/leukemias with plasmacytic differentiation 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
| Arm | Type | Receives |
|---|---|---|
| This is a single arm treatment of CAR19BCMA CAR-T cell | Experimental | Genetic: CAR19BCMA-T cells, Drug: fludarabine and cyclophosphamideExperimental: CAR19BCMA-T cells Therapy Investigational product: CAR19BCMA-T cells Route of administration: Intravenous injection Lymphodepleting chemotherapy regimen: A combination of fludarabine and cyclophosphamide will be administered prior to the infusion of CD19BCMA-CAR-T cells. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Relapsed/refractory CD19BCMA positive plasma cell neoplasms and lymphomas/leukemias with plasmacytic differentiation must be assured and meet all of the following conditions:
- Age 18-80 years, no gender restrictions
- ECOG score ≤ 2 points
- Expected survival period is not less than 3 months
- HGB≥60g/L
Key exclusion criteria (10 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
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. | Genetic | This is a single arm treatment of CAR19BCMA CAR-T cell |
| fludarabine and cyclophosphamideDrug: 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/m2/day intravenously (IV) for 3 days prior to the infusion of CD19BCMA-CAR-T cells. | Drug | 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 and lymphomas/leukemias with plasmacytic differentiation.
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 and lymphomas/leukemias with plasmacytic differentiation.
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 and lymphomas/leukemias with plasmacytic differentiation.
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 8 Apr 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.
1 site 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 and fludarabine and cyclophosphamide in people with Relapsed or Refractory Plasma Cell Neoplasms and Lymphomas/Leukemias With Plasmacytic Differentiation, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site 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 13 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: opening soon, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Hongmei Ning, Dr (+86 01066947164, ninghongmei72@sina.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 and lymphomas/leukemias with plasmacytic differentiation. (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 8 Apr 2026.