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| Name | Class |
|---|---|
| Hebei Medical University Fourth Hospital | OTHER |
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This is an open, single-arm, prospective,clinical study to evaluate efficacy and safety of Auto CAR-T cell injection in the treatment of recurrent or refractory Hematopoietic and Lymphoid Tissue Tumors in Children
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 month post CAR-T cells infusion |
| Efficacy: Remission Rate | Remission Rate including complete remission(CR)、partial response(PR)、No remission(NR)、progressive disease(PD) | 3 months post CAR-T cells infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy:duration of response (DOR) | duration of response (DOR) | 24 months post CAR-T cells infusion |
| Efficacy: progression-free survival (PFS) | progression-free survival (PFS) time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianqiang Li, PhD&MD | Contact | 008615511369555 | limmune@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Lian Jiang, MD | Hebei Medical University Fourth Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric hematology, Hebei Medical University Fourth Hospital | Recruiting | Shijiazhuang | Hebei | 050000 | China |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic 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 |
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| Drug |
Drug: Cyclophosphamide,Fludarabine |
|
| Leukapheresis | Procedure | Leukapheresis |
|
| 24 months post CAR-T cells infusion |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D047589 |
| Leukocyte Reduction Procedures |
| D002469 | Cell Separation |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D008919 | Investigative Techniques |