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| Name | Class |
|---|---|
| Hrain Biotechnology Co., Ltd. | INDUSTRY |
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The goal of this clinical trial is to study the safety and feasibility of anti- Mesothelin Chimeric Antigen Receptor T-Cell (MESO CAR-T cells) therapy for Refractory-Relapsed Ovarian Cancer
Primary Objectives:
1. To determine the safety and feasibility of anti- MESO CAR-T cells therapy for Refractory-Relapsed Ovarian Cancer
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anti- MESO CAR-T cells | Experimental | The subjects in this arm will receive Cyclophosphamide 300mg/m2/d and Fludarabine 30mg/m2/d d-4~-2. Then anti- MESO CAR-T cells will be injected by a dose of 5×106/kg once at d1(rang from d1-3). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti- MESO CAR-T cells | Drug | Autologous genetically modified anti- MESO CAR transduced T cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) and Serious adverse event (SAEs) | Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.03 | 1 year post infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | the highest concentration (Cmax) of anti-human MESO T cells in the peripheral blood after administration | 30 days post infusion |
| Tmax | the time to reach the highest concentration (Tmax) of anti-human MESO T cells in the peripheral blood after administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui Zhao, doctor | Contact | 021-64369181 | ivy25502@hotmail.com | |
| Yincheng Teng, doctor | Contact | 021-64369181 | teng_yc@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Hui Zhao, doctor | Shanghai 6th People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai 6th People's Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| Fludarabine | Drug | Dose: 30mg/m2/d |
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| Cyclophosphamide | Drug | Dose: 300mg/m2/d |
|
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| 30 days post infusion |
| AUC(0-30d) | the area under the curve of 30 days of anti-human MESO T cells in the peripheral blood after administration | 30 days post infusion |
| Duration of Mesothelin-positive T cells in circulation | Duration of Mesothelin-positive T cells in circulation | 90 days post infusion |
| ORR | Overall response rate after administration | 3 months post infusion |
| PFS | Progress Free Survival after administration | 1 year post infusion |
| EORTC Quality-of-Life Questionnaire Core 15 Palliative Care (QLQ-C15-PAL) of patients after administration | This QLQ-C15-PAL score consists of 15 questions; two multi-item functional scales (physical and emotional functioning), two multi-item symptom scales (fatigue and pain) together with five single-item symptom scales (nausea/vomiting, dyspnea, insomnia, appetite loss, constipation) and one final question referring to overall QOL. The physical functioning scale is based on three questions regarding walking, activities of daily living and time spent in bed or in a chair. The emotional functioning scale is based on two questions that ask about feeling tense or depressed. Patients rated each question on a Likert scale from 1 (not at all) to 4 (very much), with the exception of overall QOL, which was rated from 1 (very poor) to 7 (excellent) | 1 year post infusion |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |