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| Name | Class |
|---|---|
| Juventas Cell Therapy Ltd. | INDUSTRY |
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Evaluate the safety and efficacy of Inaticabtagene autoleucel combined with autologous hematopoietic stem cell transplantation in adolescents or adults with MRD-positive initial complete remission in B-cell acute lymphoblastic leukemia.
Evaluate the safety and efficacy of Inaticabtagene autoleucel combined with autologous hematopoietic stem cell transplantation in adolescents or adults with MRD-positive initial complete remission in B-cell acute lymphoblastic leukemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inaticabtagene autoleucel Combined with Autologous Hematopoietic Stem Cell Transplantation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inaticabtagene autoleucel | Biological | CNCT19 combined with autologous hematopoietic stem cell transplantation,Dose: (0.5 -2)x 10^6/kg CNCT19 Cell Injection via intravenous infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse-Free Survival | The time from the start of infusion of Inaticabtagene autoleucel until the diagnosis of relapse or any death (whichever comes first). | From autologous hematopoietic stem cell transplantation to 2 years after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival rate | From autologous hematopoietic stem cell transplantation to 2 years after transplantation | |
| Cumulative recurrence rate | From autologous hematopoietic stem cell transplantation to 2 years after transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Hematology, Chinese Academy of Medical Sciences | Recruiting | Tianjin | Tianjin Municipality | 300000 | China |
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| MRD negativity rate | 28 days after the first CAR-T cell reinfusion |
| ID | Term |
|---|---|
| D002051 | Burkitt Lymphoma |
| D018365 | Neoplasm, Residual |
| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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