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This is a single arm study to evaluate the efficacy and safety of BCMA-targeted prime CAR-T cells therapy for patients with relapsed/refractory Multiple Myeloma.
There are limited options for treatment of relapse/refractory Multiple Myeloma. BCMA is expressed on most Multiple Myeloma cells so it is an ideal target for CAR-T. In this study, investigators will evaluate the safety and efficacy of prime CAR- T targeting BCMA in patients with relapsed/refractory Multiple Myeloma. The primary goal is safety and efficiency assessment, including adverse events and disease status after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BCMA targeted prime CAR-T cells treat | Experimental | Patients will be be treated with BCMA targeted prime CAR-T cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCMA targeted prime CAR-T cells | Biological | BCMA targeted prime CAR-T cell therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events that related to treatment | Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0) | 2 years |
| The response rate of BCMA targeted prime CAR-T treatment in patients with relapse/refractory Multiple Myeloma that treatment by BCMA targeted prime CAR-T cells therapy | The response rate of BCMA targeted prime CAR-T treatment will be recorded and assessed according to the IMWG | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of BCMA targeted prime CAR-T cells in bone marrow and peripheral blood | In vivo (bone marrow and peripheral blood) rate of BCMA targeted prime CAR-T cells were determined by means of flow cytometry | 2 years |
| Quantity of BCMA targeted prime CAR copies in bone marrow and peripheral blood |
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Inclusion Criteria:
Signed written informed consent;
Diagnose as relapsed /refractory multiple myeloma or other plasma cell disease, and meet one of the following conditions:
Evidence for cell membrane BCMA expression
All genders, ages: 18 to 75 years#
The expect time of survive is above 3 months;
KPS>60
No serious mental disorders ;
Left ventricular ejection fraction ≥50%
Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
Sufficient renal function defined by creatinine clearance≤2 x ULN;
Sufficient pulmonary function defined by indoor oxygen saturation≥92%; 12. With single or venous blood collection standards, and no other cell collection contraindications;
13. Ability and willingness to adhere to the study visit schedule and all protocol requirements.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhi Yang, PhD | Contact | 86-13206140093 | yangzhi@precision-biotech.com |
| Name | Affiliation | Role |
|---|---|---|
| Sanbin Wang, MD | 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China | Principal Investigator |
| Cheng Qian, PhD | Chongqing University Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 920th Hospital of Joint Logistics Support Force | Recruiting | Kunming | Yunnan | China |
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In vivo (bone marrow and peripheral blood) quantity of BCMA targeted prime CAR copies were determined by means of qPCR |
| 2 years |
| Quantity of clonal plasma cells in bone marrow | In vivo (bone marrow) quantity of clonal plasma cells | 1 years |
| Levels of IL-6 in Serum | In vivo (Serum) quantity of IL-6 | 1years |
| Duration of Response (DOR) of BCMA targeted prime CAR-T treatment in patients with refractory/relapsed multiple myeloma | DOR will be assessed from the first assessment of sCR/CR/VGPR/PR to the first assessment of recurrence or progression of the disease or death from any cause (censored) | 2 years |
| Progress-free survival(PFS) of BCMA targeted prime CAR-T treatment in patients with refractory/relapsed multiple myeloma | PFS will be assessed from the first prime CAR-T cell infusion to death from any cause or the first assessment of progression (censored) | 2 years |
| Overall survival(OS) of BCMA targeted prime CAR-T treatment in patients with refractory/relapsed multiple myeloma | OS will be assessed from the first prime CAR-T cell infusion to death from any cause (censored) | 2 years |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| 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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