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| Name | Class |
|---|---|
| Anhui Provincial Hospital | OTHER_GOV |
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The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell immunotherapy in patients with CD19 positive relapsed or refractory Leukemia and Lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCAR-019 | Experimental | Enrolled patients will receive PCAR-019 with a novel specific chimeric antigen receptor targeting CD19 antigen by infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCAR-019 (anti-CD19 CAR-T cells) | Biological |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: Adverse events attributed to the administration of PCAR-019 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Phase II: Objective Response Rate | 2 years |
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Inclusion Criteria:
Male and female subjects with CD19+ B cell malignancies in patients with no available curative treatment options (such as autologous or allogeneic SCT) who have limited prognosis (several months to < 2 year survival) with currently available therapies will be enrolled:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin Yang, Ph.D. | Contact | 86-512-65922190 | info@persongen.com |
| Name | Affiliation | Role |
|---|---|---|
| Xingbing Wang, Ph.D. | Anhui Provincial Hospital | Principal Investigator |
| Xin Liu, Ph.D. | Anhui Provincial Hospital | Principal Investigator |
| Lin Yang, Ph.D. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PersonGen BioTherapeutics (Suzhou) Co., Ltd. | Recruiting | Suzhou | Jiangsu | 215123 | China |
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| PersonGen BioTherapeutics (Suzhou) Co., Ltd. |
| Principal Investigator |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D054403 | Leukemia, Prolymphocytic, B-Cell |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D015463 | Leukemia, Prolymphocytic |
| D016393 | Lymphoma, B-Cell |
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| ID | Term |
|---|---|
| D016219 | Immunotherapy, Adoptive |
| D012680 | Sensitivity and Specificity |
| D018941 | Antigens, CD19 |
| ID | Term |
|---|---|
| D019264 | Adoptive Transfer |
| D007116 | Immunization, Passive |
| D007114 | Immunization |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D013223 | Statistics as Topic |
| D055641 | Mathematical Concepts |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015703 | Antigens, CD |
| D000943 | Antigens, Differentiation |
| D000954 | Antigens, Surface |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D000944 | Antigens, Differentiation, B-Lymphocyte |
| D015778 | Minor Histocompatibility Antigens |
| D006649 | Histocompatibility Antigens |
| D007519 | Isoantigens |
| D015415 | Biomarkers |
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