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| Name | Class |
|---|---|
| Shanghai AbelZeta Ltd. | INDUSTRY |
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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 patients.
The study will include the following sequential phases: Screening, Apheresis, Baseline, Pre-Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), C-CAR088 infusion and Follow-up Visit.
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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 |
|---|---|---|
| The Incidence of adverse events (TEAEs) within 30 days after intravenous infusion of C-CAR088 | 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;
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;
At least 2 weeks from monoclonal antibody therapy prior to CAR T cell therapy.
ECOG scores 0 - 1;
Good cardiac and pulmonary organ function;
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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daobin Zhou, PhD&MD | Contact | 010-69155020 | zhoudb@pumch.cn | |
| Lu Zhang | Contact | 010-69155660 | pumczhanglu@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Daobin Zhou | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100010 | 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 |
| 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 |