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The purpose of this study is to evaluate the safety and efficiency of CD19-Targeted CAR-T in Treating Patients with relapsed/refractory acute leukemia.
The relapsed/refractory ALL patients will receive FC (F,Fludarabine,C,Cyclophosphamide) chemotherapy followed by infusion of allogenic or autologous CD19-Targeted CAR-T cells.No graft-versus-host disease (GVHD) prevention will be conducted before or after infusion. Dose-limiting toxicity,incidence of adverse events and disease response will be detected post-infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CART-19 | Experimental | The relapsed/refractory ALL patients will receive allogenic or autologous CD19-Targeted CAR-T cells infusion after FC chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CART-19 cells | Biological | CD19-Targeted CAR-T cells are infused to patient received FC chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity | 28 days | |
| Incidence of adverse events as assessed | 3 months | |
| Disease response (CR or CRi) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Engraftment of transferred CD19+ CAR T cells | 28 days | |
| CAR19-specific antibody level | 6 months | |
| Duration of response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| HUISHENG AI | Contact | 8610-66947126 | HUISHNGAI@163.COM | |
| MEI GUO | Contact | 8610-66947135 |
| Name | Affiliation | Role |
|---|---|---|
| HUISHENG AI | 307 Hospital of PLA | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 307 Hospital of PLA | Recruiting | Beijing | Beijing 100071 | 100071 | China |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| 1year |
| Progression Free Survival | 1year |
| Survival | 1year |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |