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| Name | Class |
|---|---|
| Juventas Cell Therapy Ltd. | INDUSTRY |
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In this single-center, open-label, no control, prospective clinical trial, a total of 10 relapsed or refractory CD19 positive B-cell Non-Hodgkin Lymphoma (NHL) patients will be enrolled.CD19 CAR T cells(total dose of 2×10^6/kg-1×10^7/kg) will be intravenously infused to patient in a three-day split-dose regimen: 10% on day 0, 30% on day 1 and 60% on day 2. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells in patients with relapsed or refractory CD19 positive B-cell lymphoma.
In this single-center, open-label, nonrandomized, no control, prospective clinical trial, a total of 10 relapsed or refractory CD19+ B-cell Non-Hodgkin Lymphoma (NHL) patients will be enrolled. CD19 CAR T cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:4-1BB, will be administered by i.v. injection in a three-day split-dose regimen: 10% on day 0, 30% on day 1 and 60% on day 2. Side effects of CD19 CAR T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells therapy in patients with relapsed or refractory CD19 positive B-cell lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD19 CAR T cells | Experimental | CD19 CAR T cells will be intravenously infused to patient in a three-day split-dose regimen: 10% on day 0, 30% on day 1 and 60% on day 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD19 CAR T cells | Biological | CD19 CAR T cells was transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:4-1BB. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of the adverse events | 2 years | |
| Response rate | 12 months | |
| Progression-free survival(PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dehui Zou, Dr. | Institute of Hematology & Blood Diseases Hospital, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital | Tianjin | 300020 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40960310 | Derived | Liu W, Xie T, Zhang Z, Huang W, Liu H, Sui W, Deng S, Lyu R, Wang Y, Wang Q, Xiong W, Xu Y, Lyu L, Ma Y, Qiu L, Wang J, Zou D. Long-term outcomes of CNCT19 chimeric antigen receptor T-cell therapy in relapsed or refractory aggressive B-cell lymphoma. Chin Med J (Engl). 2026 May 5;139(9):1367-1374. doi: 10.1097/CM9.0000000000003716. Epub 2025 Sep 17. |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D012008 | Recurrence |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| 2 years |
| Persistence of CAR T cells in vivo | 2 years |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |