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| Name | Class |
|---|---|
| PersonGen BioTherapeutics (Suzhou) Co., Ltd. | INDUSTRY |
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | OTHER |
| Affiliated Hospital of Jiangnan University | OTHER |
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This is a prospective, open-label, multiple center and single arm phase 2 study to evaluate the efficacy and safety of T cells expressing humanized CD7 chimeric antigen receptors treatment for patients with refractory/relapsed CD7 positive T cell lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD7 positive relapsed or refractory T cell lymphoma | Experimental | Humanized CD7 CAR-T cells intravenously infused to patient with R/R T-NHL[ at a dose of (0.5- 5)x10^6 CD7 CAR-T cells/kg](streamdown:incomplete-link) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Humanized CD7 CAR-T cells | Biological | Patients will receive infusion of CAR T-cells targeting CD7 to confirm the safety and efficacy of CD7 CAR T-Cells in CD7+ relapsed or refractory T cell lymphoma |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | Number of patients who achieved response (complete response and partial response ) after treatment of CD7 CAR-T cell. Response will be assessed using the Lugano criteria. | 1 year |
| Number of Adverse Events | Adverse events are evaluated with CTCAE V5.0 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Complete relapse rate(CR) | Number of patients who achieved complete response after treatment by CD7 CAR-T cell. | 1 year |
| Duration of overall response (DOR) | Duration of overall response will be assessed from the CAR-T cell infusion to progression, death or last follow-up. |
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Inclusion Criteria:
Age ≥ 18 years
R/R T-NHL with measurable (≧1.5cm) lesions confirmed by pathological immunohistochemistry or flow cytometry
The expressions of both CD4 and CD8 are negative in patients with bone marrow involved
The Eastern Cooperative Oncoloy Group (ECOG) physical condition score ≤ 2 points
The main organ functions need to meet the following conditions:
A.Left ventricular ejection fraction ≥50% B.Creatinine ≤132umol/l or creatinine clearance ≥60 ml/min C.ALT and AST≤2.5 upper limitation of normal D.T-BIL≤2.0mg/dl E.SpO2 > 90%
Results of pregnant test should be negative, and agree to conception control during treatment and 1 year after CAR-T infusion
Expected survival exceeds 3 months
Written informed consent could be acquired
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caixia Li, M.D | Contact | +86 512 67781856 | licaixia@suda.edu.cn | |
| Jia Chen, M.D | Contact | +86 512 67781856 | chenjiasuzhou@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Depei Wu, M.D&Ph.D | The First Affiliated Hospital of Soochow University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215000 | China |
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| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Affiliated Zhongshan Hospital of Dalian University | OTHER |
| The First Affiliated Hospital of Dalian Medical University | OTHER |
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| 1 year |
| Progression-free survival(PFS) | PFS will be assessed from the CAR-T cell infusion to progression, death or last follow-up. | 1 year |
| Overall survival(OS) | OS will be assessed from the CAR-T cell infusion to death or last follow-up. | 1 year |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |