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| Name | Class |
|---|---|
| Hebei Medical University Fourth Hospital | OTHER |
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This study is a multi-center, non-randomized, single-arm, open clinical trial.
A single car consists of scFv, hinge region, transmembrane region, costimulatory domain and zeta subunit of CD3.Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auto CAR-T | Experimental | Patients will be treated with Auto CAR-T cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auto CAR-T | Biological | Biological: Auto CAR-T |
| |
| Cyclophosphamide,Fludarabine |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence and severity of adverse events | To evaluate the possible adverse events occurred within first one month after CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity | first one month after CAR-T infusion |
| Efficacy: Remission Rate | Remission Rate including complete remission (CR), partial remission (PR), objective response (ORR = CR + PR), disease stability (SD), disease progression (PD) and unresponsive (NR) | 3 months post CAR-T cells infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy:duration of response (DOR) | duration of response (DOR) | 24 months after CAR-T infusion |
| Efficacy: progression-free survival (PFS) | progression-free survival (PFS) time |
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Inclusion Criteria:
Fully understand and voluntarily sign the informed consent form, and be willing and able to comply with the visits, treatment plans, laboratory inspections, and other requirements of the research as specified in the test procedure;
Patients with relapsed/refractory plasma cell tumors determined by clinical diagnosis;
The definition of relapsed/refractory plasma cell tumors is:
According to RECIST version 1.1 , there should be at least one measurable tumor (soft tissue mass) or serum M protein ≥10g/L or urine M protein ≥200mg/24h;
Subjects whose physical status scored by the Eastern Cooperative Oncology Group (ECOG) is 0~2;
14 years old ≤ age ≤ 75 years old, both male and female;
Immunohistochemistry or flow cytometry detects tumor cells as BCMA or CD19/CD22/CD79 positive;
The estimated survival period from the date of signing the informed consent form is greater than 3 months;
Laboratory examinations meet the following conditions: hemoglobin ≥80g/L, platelet count ≥50 × 109/L, absolute neutrophil count (ANC) ≥1.0 × 109/L, if the investigator believes that the above inspection value is below the lower limit It is caused by tumor invading bone marrow and can be included in the group after consultation with the sponsor;
The main organ function indicators meet the following conditions: AST (aspartate aminotransferase)/ALT (alanine aminotransferase)/ALP (alkaline phosphatase) ≤2.5 ULN, serum creatinine ≤1.5 ULN, total bilirubin ≤1.5 ULN, left Ventricular ejection fraction (LVEF) ≥50%, and minimum pulmonary function reserve (dyspnea is not higher than grade 1 and blood oxygen saturation> 92% under indoor conditions).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianqiang Li, PhD & MD | Contact | 008615511369555 | limmune@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Baoen Shan, PhD & MD | Hebei Medical University Fourth Hospital | Principal Investigator |
| Lihong Liu, PhD & MD | Hebei Medical University Fourth Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hematology Department, Hebei Medical University Fourth Hospital | Recruiting | Shijiazhuang | Hebei | 050000 | China |
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| Drug |
Drug: Cyclophosphamide,Fludarabine |
|
| Leukapheresis | Procedure | Leukapheresis |
|
| 24 months after CAR-T infusion |
| ID | Term |
|---|---|
| D010954 | Plasmacytoma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C095424 | CF regimen |
| D007937 | Leukapheresis |
| ID | Term |
|---|---|
| D016238 | Cytapheresis |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D001781 | Blood Component Removal |
| D047589 | Leukocyte Reduction Procedures |
| D002469 | Cell Separation |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D008919 | Investigative Techniques |
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