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| ID | Type | Description | Link |
|---|---|---|---|
| 2025KY072-KS001 | Other Identifier | Ethics Committee of Chinese PLA General Hospital |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| This is a single arm treatment of CAR19BCMA CAR-T cell | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAR19BCMA-T cells | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | MTD will be determined based on DLTs observed during the first 28 days of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| According to the pharmacokinetics (number of CAR-T cells in peripheral blood was measured to evaluate the persistence of CAR-T cells) to explore the kinetics and clonal evolution of CAR19BCMA CAR-T cells. | Up to 12 months after CAR-T treatment |
Inclusion Criteria:
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;
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Liu Dr | Contact | +86 186 0031 0985 | 18600310985@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Four Medical Center of PLA General Hospital, China | Beijing | China |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009370 | Neoplasms by Histologic Type |
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CAR-T
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| Within 3 months following infusion of CAR19BCMA CAR-T cells |
| The Six Medical Center of PLA General Hospital, China | Beijing | China |
|
| D009369 | Neoplasms |