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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 MUC1 positive relapsed or refractory solid tumor.
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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 MUC1 antigen by infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-MUC1 CAR-pNK cells | Biological |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: Adverse events attributed to the administration of the anti-MUC1 CAR-pNK cells | Determine the toxicity profile of the MUC1 targeted CAR-pNK cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Phase II: Objective Response Rate | The objective response rate (ORR) is defined as the proportion of patients who achieve radiographic partial or complete response (PR or CR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guideline. | 2 years |
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Inclusion Criteria:
Male and female subjects with MUC1+ 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 |
|---|---|---|---|
| 41121171 | Derived | Lin J, Xu W, Xia L, Zhang C, Ge L, Gao J, Bao J, Xu Y, Sun X, Li H, Wang Y. A phase I trial of combination CAR-NK92MI immunotherapy by dual targeting MUC-1 and PD-L1 for patients with relapsed or refractory solid tumors: focus on non-small cell lung cancer. BMC Pulm Med. 2025 Oct 21;25(1):482. doi: 10.1186/s12890-025-03944-y. | |
| 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 |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D010190 | Pancreatic Neoplasms |
| D015179 | Colorectal Neoplasms |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D013272 | Stomach Diseases |
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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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