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This is a single-center, non-randomized and dose-escalation study to evaluate the safety and efficacy of C-CAR088 in relapsed or refractory multiple myeloma patient.
The study will include the following sequential phases: Screening, Pre- Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), C-CAR088 infusion and Follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C-CAR088 | Experimental | Lymphocytes will be transduced with lentiviral vector containing CAR-BCMA gene. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C-CAR088 | Drug | Autologous BCMA-directed CAR-T cells, single infusion intravenously at a target dose of 1.0-9.0 x 10^6 anti-BCMA CAR+T cells/kg. Other Name: CBM.BCMA Chimeric Antigen Receptor T cell. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: The incidence of treatment-emergent adverse events (TEAEs) | The incidence of treatment-emergent adverse events (TEAEs) | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | ORR(including sCR / CR / VGPR / PR, based on IMWG 2016 efficacy evaluation criteria) | 12 months |
| Progression free survival (PFS) | PFS(based on IMWG 2016 efficacy evaluation criteria) |
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Inclusion Criteria:
Age 18-75 years old, male or female;
The patient volunteered to participate in the study, and he or his legal guardian signed the Informed Consent;
Meet the internationally accepted Criteria for the diagnosis of multiple myeloma (IMWG diagnostic criteria 2014);
Patients with a clear diagnosis of relapsed or refractory multiple myeloma;
The patient have one or more measurable multiple myeloma lesion, must include one of the following conditions:
Bone marrow sample is confirmed as BCMA-positive by flow cytometry or pathological examination;
ECOG scores 0 - 1;
Echocardiography showed normal diastolic function, left ventricular ejection fraction (LVEF) ≥50%, and no severe arrhythmia;
No active pulmonary infections, normal pulmonary function and oxygen saturation ≥ 92% on room air.
Absolute neutrophil count ≥1.0 × 109 / L, platelet count ≥50 × 109 / L; total serum bilirubin ≤1.5mg / dl; serum ALT or AST less than 2.5 times the upper limit of normal; serum creatinine ≤2.0mg / dl;
No contraindications of peripheral blood apheresis;
Expected survival time > 12 weeks;.
Female subjects of childbearing age must have a negative urine / blood pregnancy test within 7 days before cell therapy and not be in lactation; female or male subjects of childbearing age need to take effective contraception throughout the study.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| InstituteHBDH | Tianjin | 300000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36100310 | Derived | Qu X, An G, Sui W, Wang T, Zhang X, Yang J, Zhang Y, Zhang L, Zhu D, Huang J, Zhu S, Yao X, Li J, Zheng C, Zhu K, Wei Y, Lv X, Lan L, Yao Y, Zhou D, Lu P, Qiu L, Li J. Phase 1 study of C-CAR088, a novel humanized anti-BCMA CAR T-cell therapy in relapsed/refractory multiple myeloma. J Immunother Cancer. 2022 Sep;10(9):e005145. doi: 10.1136/jitc-2022-005145. |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| 6 months、12 months |
| The CART cell duration in vivo | The copys of BCMA-CART DNA in peripheral blood with qPCR method | 12 months |
| The soluble BCMA changes in peripheral blood | The amount of soluble BCMA in peripheral blood with ELISA method | 12 months |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |