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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 effectiveness of CAR-pNK cell immunotherapy in patients with CD7 positive relapsed or refractory Leukemia and Lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAR-pNK Cell immunotherapy | Experimental | Enrolled patients will receive CAR-pNK cell immunotherapy with a novel specific chimeric antigen receptor targeting CD7 antigen by infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-CD7 CAR-pNK cells | Biological | The allogeneic NK cells (NK-92 cell line for clinical use) are engineered to contain anti-CD7 attached to TCRzeta, CD28 and 4-1BB signaling domains. These modified cells are called chimeric antigen receptor NK cells with specificity for CD7. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events attributed to the administration of the anti-CD7 CAR-pNK cells | Determine the toxicity profile of the CD7 targeted CAR-pNK cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response to CD7 CAR-pNK cell infusions | Patients with measurable disease will be assessed for the response of their disease to CD7 CAR-pNK cell treatment. | Safety follow-up is 100 days from last CAR-pNK infusion |
| Determine the existence of CD7-CAR-pNK in vivo |
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Inclusion Criteria:
Male and female subjects with CD7+ malignancies in patients with no available curative treatment options 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 |
|---|---|---|
| Lin Yang, Ph.D. | PersonGen BioTherapeutics (Suzhou) Co., Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PersonGen BioTherapeutics (Suzhou) Co., Ltd. | Recruiting | Suzhou | Jiangsu | 215123 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28054442 | Derived | 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. |
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|
|
| 1 year |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| D015461 | Leukemia, Prolymphocytic, T-Cell |
| D054066 | Leukemia, Large Granular Lymphocytic |
| D016399 | Lymphoma, T-Cell |
| D007119 | Immunoblastic Lymphadenopathy |
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| D058527 | Enteropathy-Associated T-Cell Lymphoma |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015463 | Leukemia, Prolymphocytic |
| D015458 | Leukemia, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D000072281 | Lymphadenopathy |
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| ID | Term |
|---|---|
| D012680 | Sensitivity and Specificity |
| 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 |
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