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| Name | Class |
|---|---|
| Beijing Lu Daopei Hospital | OTHER |
| Hebei Yanda Ludaopei Hospital | OTHER |
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This is a study of patients with relapsed or refractory non-Hodgkin's lymphoma. To evaluate the safety and efficacy of SL1904B in patients with relapsed or refractory non-Hodgkin's lymphoma.
The CARs consist of an anti-CD19 single-chain variable fragment(scFv) that was derived from the FMC63 mouse hybridoma, a portion of the human CD137(4-1BB) molecule, and the intracellular component of the human CD3ζ molecule. 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.
The Main research objectives:
To evaluate the safety and efficacy of SL1904B in patients with recurrent or refractory non-Hodgkin's lymphoma
The Secondary research objectives:
To investigate the cytokinetic characteristics of SL1904B in patients with recurrent or refractory non-Hodgkin's lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SL1904B CAR-T | Experimental | Patients will be treated with CD19 CAR-T cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD19 CAR-T | Biological | Biological: CD19 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis; |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence and severity of adverse events | To evaluate the possible adverse events occurred within first one month after SL1904B infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity | First month post CAR-T cells infusion |
| Efficacy: Overall Remission Rate (ORR) | Overall Remission Rate (ORR) including partial remission and complete remission rate after infusion of SL1904B | 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 | |
|---|---|---|---|---|
| Peihua Lu, PhD&MD | Contact | 008618611636172 | peihua_lu@126.com | |
| Jianqiang Li, PhD&MD | Contact | 008615511369555 | limmune@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Peihua Lu, PhD&MD | Beijing Lu Daopei Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BeiJing Ludaopei Hospital | Recruiting | Beijing | Yizhuang | 100000 | China |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| 24 months post CAR-T cells infusion |
| CAR-T proliferation | the copy number of CD19 CAR- T cells in the genomes of PBMC by qPCR method and percentage of CD19 CAR- T cells measured by flow cytometry method | 3 months post CAR-T cells infusion |
| Cytokine release | Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method | First month post CAR-T cells infusion |
| He bei Yan da Lu dao pei Hospital | Recruiting | Yanda | China |
|
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |