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**Translation:**
This clinical trial is designed as a single-arm, open-label, multicenter study. After signing the informed consent form, eligible subjects will undergo a single nucleated cell collection for the preparation of CAR-T cells. Following lymphodepletion pretreatment, a single infusion of PA3-17 injection will be administered. Blood samples will be collected from the subjects before and after the infusion for pharmacokinetic, pharmacodynamic, immunogenicity, and safety evaluations. In addition to the baseline period, the treatment phase will involve efficacy assessments at 4 weeks, 2 months, 3 months, and every 3 months thereafter, up to 24 months post-cell infusion. Tumor assessments will continue until disease progression (PD), initiation of new antitumor treatment, death, unacceptable toxicity, investigator decision, or subject's voluntary withdrawal, whichever occurs first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T cell injection targeting CD7 chimeric antigen receptor | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T cell injection targeting CD7 chimeric antigen receptor | Biological | After signing the informed consent form, eligible subjects will undergo a single nucleated cell collection for the preparation of CAR-T cells, followed by lymphodepletion pretreatment and a single infusion of PA3-17 injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Three-month Objective Response Rate (ORR): Proportion of Composite Complete Response Rate (CRc: CR, CRh, CRi, MLFS) and PR | Three months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaojun Huang, MD | Contact | +86-13701389625 | xjhrm@medmail.com.cn | |
| Mingzhi Zhang, MD | Contact | 037166295562 | mingzhi_zhang@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital) | Recruiting | Hefei | Anhui | 230000 | China |
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| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
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| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
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| Sun Yat-sen University Cancer Center (SYSUCC) | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| Facility Name: Guangdong Provincial People's Hospital | Not yet recruiting | Guangzhou | Guangdong | 510080 | China |
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| The First Hospital of Harbin | Not yet recruiting | Harbin | Heilongjiang | 150000 | China |
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| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450000 | China |
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| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | China |
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| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430000 | China |
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| Jiangsu Province Hospital | Recruiting | Nanjing | Jiangsu | 210000 | China |
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| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215000 | China |
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| The Affiliated Hospital of Xuzhou Medical University | Recruiting | Xuzhou | Jiangsu | 221000 | China |
|
| Tongji Hospital, Tongji University | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| West China Hospital, Sichuan University (WCHSU) | Recruiting | Chengdu | Sichuan | 610000 | China |
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| Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences | Recruiting | Tianjin | Tianjin Municipality | 300000 | China |
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| The First Affiliated Hospital, Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | Zhejiang | 310000 | China |
|