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| Name | Class |
|---|---|
| Chinese Academy of Sciences | OTHER_GOV |
| Navy General Hospital, Beijing | OTHER |
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The major aim of this research is to assess the feasibility, safety and effectiveness of CD19 CAR-T Cell Therapy for Relapsed/ Refractory Acute Lymphoblastic Leukemia/ B cell Lymphoma patients who have applied it.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PZ01 CAR-T Cells | Experimental | This is a phase I study. Patients with relapsed/ refractory B-cell Acute Lymphoblastic Leukemia/B cell Lymphoma are eligible for enrollment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PZ01 CAR-T cells | Drug | Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with relapsed/ refractory B-cell Acute Lymphoblastic Leukemia/B cell Lymphoma. The CAR consists of a CD19 targeting antibody scFv with two intracellular signaling domains derived from CD3 zeta and 4-1BB. Autologous T cells will be gene-engineered with the CAR gene using a lentivirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment Related Adverse Events | To evaluate the safety of adoptive transfer of gene-modified autologous CD19-specific T cells in relapsed/ refractory B-cell Acute Lymphoblastic Leukemia/B cell Lymphoma. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | Proportion of patients with reduction in tumor burden. | 2 months |
| Overall survival (OS) | Time from study enrollment until death. |
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Inclusion Criteria:
Subjects or their legal guardians participate in this experiment voluntarily and informed consent form must be signed
In accordance with National Comprehensive Cancer Network (NCCN) ALL Guidelines for Patients (2016, v.1) and CD19+B-ALL/B cell lymphoma patients diagnosed by histology
In accordance with r/r CD19+ B-ALL/B cell lymphoma diagnosis, including any of the following situations:
Remedial chemotherapy is not used within 4 weeks before cell therapy
Immunosuppressive drug is not used within 4 weeks before cell therapy, including but not limited to systemic hormone therapy
Antibody drug treatment is not received within 2 weeks before cell therapy
Normal cardiac motion shown by echocardiography, left ventricular ejection fraction (LVEF) ≥50%, with no pericardial effusion and severe symptoms of cardiac arrhythmia
No pulmonary active infection is found, with normal pulmonary function and indoor air SaO2 ≧92%
No contraindications for leukapheresis
Expected survival >3 months
Grade 0 or 1 of ECOG performance status
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guoyan Wang | Contact | +86-018661838188 | 648818685@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Shengdian Wang | Insitute of Biophysics,Chinese Academy of Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hematology, Navy General Hospital of PLA | Recruiting | Beijing | Beijing Municipality | 100048 | China |
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| ID | Term |
|---|---|
| D002051 | Burkitt Lymphoma |
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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|
| 6 months |
| Minimal residual disease negative remission rate(MRD) | Proportion of MRD-negative patients. | 2 months |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| 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 |