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CAR-T cell therapy has shown promising results for the treatment of relapsed or refractory Multiple Myeloma,however, a subset of patients relapse due to the loss of target in tumor cells.Dual Specificity CD38 and BCMA CAR-T cells can recognize and kill the malignant cells through recognition of CD38 or BCMA. This is a phase 1/2 study designed to determine the safety of dual specificity CD38 and BCMA CAR-T cells and the feasibility of making enough to treat patients with relapsed or refractory Multiple Myeloma.
PRIMARY OBJECTIVES:
SECONDARY OBJECTIVES:
1.For patients with detectable disease, measure anti-tumor response due to dual specificity CD38 and BCMA CAR-T cell infusions.
2.The CAR-T cells will be administered by i.v. injection over 20-30 minutes as a using Day 0: 1-5x10e6/kg total dose on day 0.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual Specificity CD38 and bcma CAR-T Cells | Biological | 1) Biological: Dual Specificity CD38 and BCMA CAR-T Cells,2)1-5X10E6/Kg |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Severe/Adverse Events as a Measure of Safety and Tolerability | 24weeks | |
| MTD of dual specificity CD38 and BCMA CAR-T cells | The highest dose of dual specificity CD38 and BCMA CAR-T cells that is estimated to result in defined Dose Limiting Toxicity (DLT) with the exception of allowable 'expected' AEs associated with the intravenous infusion of dual specificity CD38 and BCMA CAR-T cells | 4 weeks |
| Copies numbers of CAR in peripheral blood(PB), bone marrow(BM)and lymph nodes | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Six-month Objective response rate of complete remission and partial remission | 24 weeks | |
| Six-month Overall survival | 24 weeks | |
| Six-month Progression free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| YaJing Zhang | Contact | 86-10-55499341 | plagh@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital | Recruiting | Beijing | 100853 | China |
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| 24 weeks |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| 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 |
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