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| Name | Class |
|---|---|
| The First People's Hospital of Hefei | OTHER |
| Hefei Binhu Hospital | OTHER |
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The purpose of this study is to evaluate the safety and optimal dose of PCAR-119 in patients who are going to receive stem cell transplantation but without available treatment to achieve complete remission prior to the transplant.
The purpose of this study is to evaluate the safety and optimal dose of PCAR-119 in patients who are going to receive stem cell transplantation but without available treatment to achieve complete remission prior to the transplant. In addition, some patients who enroll to other CD19-CAR-T cell therapy trials might be eligible for this trial if their CD19-CAR-T cells cannot be produced successfully because they have insufficient T cells to allow the CD19-CAR-T cells to be made; their T cells are inefficiently transduced with CAR viruses; or their CAR-T cell expansion is failed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAR-NK Cell immunotherapy | Experimental | Enrolled patients will receive CAR-NK cell immunotherapy with a novel specific chimeric antigen receptor targeting CD19 antigen by infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-CD19 CAR-NK cells | Biological | The allogeneic NK cells (NK-92 cell line for clinical use) are engineered to contain anti-CD19 attached to TCRzeta, CD28 and 4-1BB signaling domains. These modified cells are called chimeric antigen receptor NK cells with specificity for CD19. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events attributed to the administration of the anti-CD19 CAR-NK cells | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Safety follow-up is 100 days from last CAR-NK infusion |
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Inclusion Criteria:
Male and female subjects with CD19+ B cell malignancies in patients who have no available curative treatment options except stem cell transplantation, with limited prognosis (several months to < 2 year survival) and no available treatment option to achieve complete remission prior to transplant. Some patients who have enrolled to other CD19-CAR-T cell therapy trials may be eligible if their CD19-CAR-T cells cannot be produced successfully because they have insufficient T cells to allow the CD19-CAR-T cells to be made; their T cells are inefficiently transduced with CAR viruses; or their CAR-T cell expansion is failed. All of those patients must meet the following criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin Yang, Ph.D. | Contact | 86-512-65922190 | lin.yang@persongen.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PersonGen BioTherapeutics (Suzhou) Co., Ltd. | Recruiting | Suzhou | Jiangsu | 215123 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34515338 | Derived | Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2. | |
| 28054442 |
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|
| Del Zotto G, Marcenaro E, Vacca P, Sivori S, Pende D, Della Chiesa M, Moretta F, Ingegnere T, Mingari MC, Moretta A, Moretta L. Markers and function of human NK cells in normal and pathological conditions. Cytometry B Clin Cytom. 2017 Mar;92(2):100-114. doi: 10.1002/cyto.b.21508. Epub 2017 Feb 12. |
| 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 |
|---|---|
| D012680 | Sensitivity and Specificity |
| D018941 | Antigens, CD19 |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| 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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