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This is a single-center, non-randomized 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 | Biological | 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 |
|
| 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) | 12 months | |
| Progression free survival (PFS) | 6 months, 12 months | |
| The CART cell duration in vivo |
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Inclusion Criteria:
Volunteered to participate in this study and signed informed consent.
Age 18-70 years old, male or female.
Meet the internationally accepted Criteria for the diagnosis of multiple myeloma (IMWG diagnostic criteria 2014).
Patients with relapsed or refractory multiple myeloma who meet at least one of the following conditions:
Subjects 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.
At least 2 weeks from monoclonal antibody therapy prior to CAR T cell therapy.
ECOG scores 0 - 1.
Normal cardiac diastolic function, left ventricular ejection fraction (LVEF) ≥ 50% (detected by echocardiography), no serious arrhythmia.
No active pulmonary infections, normal pulmonary function and oxygen saturation ≥ 92% on room air.
No contraindications of leukapheresis.
Expected survival > 12 weeks.
Female subjects in childbearing age, their serum or urine pregnancy test must be negative,until 7 days before cell therapy and all subjects must agree to take effective contraceptive measures during the trial.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peihua Lu, PhD&MD | Contact | +86-0316-3306393 | peihua_lu@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebei Yanda Ludaopei Hospital | Recruiting | Sanhe | Hebei | 065200 | 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 |
|---|---|
| D012008 | Recurrence |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
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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 |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| 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 |