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To evaluate the safety and efficacy of SL19+22 in patients with relapsed or refractory non-Hodgkin's lymphoma.
SL19+22 injection is a CAR-T product independently developed by Senlang that targets both CD19 and CD22. Based on the traditional CAR T treatment regimen, the CAR structure was designed, and the activation mode of T cells was changed by using cytokine combination amplification and improved transfection technology.
The Main research objectives:
To evaluate the safety and efficacy of SL19+22 in patients with recurrent or refractory non-Hodgkin's lymphoma
The Secondary research objectives:
To investigate the cytokinetic characteristics of SL19+22 in patients with recurrent or refractory non-Hodgkin's lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SL 19+22 CAR-T | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD19+22 CAR-T cells | Biological | Biological: CD19+22 CAR-T; Drug: Cyclophosphamide,Fludarabine; |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence and severity of adverse events | To evaluate the possible adverse events could occurred within first month post infusion. | 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 SL19+22 | 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&M | Contact | 008618611636172 | peihua_lu@126.com | |
| Jianqiang Li, PhD&M | Contact | 008615511369555 | limmune@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Peihua Lu, PhD&M | Hebei Yanda Ludaopei Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebei Yanda Ludaopei Hospital | Recruiting | Langfang | Hebei | 065000 | 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 and CD22 CAR- T cells in the genomes of PBMC by qPCR | 3 months post CAR-T cells infusion |
| Cytokine release | Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry | First month post CAR-T cells infusion |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |