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: 1. To access the efficacy of anti- MESO CAR-T cells in patients with ovarian cancer. 2. To determine in vivo dynamics and persistency of anti- MESO CAR-T cells 3. To assess the quality of life in patients with ovarian cancer after treatment with anti- MESO CAR-T cells.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Autologous genetically modified anti- MESO CAR transduced T cells
Dose: 30mg/m2/d
Dose: 300mg/m2/d
Shanghai 6th People's Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGAdverse events (AEs) and Serious adverse event (SAEs)
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.03
Time frame: 1 year post infusion
Cmax
the highest concentration (Cmax) of anti-human MESO T cells in the peripheral blood after administration
Time frame: 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
Time frame: 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
Time frame: 30 days post infusion
Duration of Mesothelin-positive T cells in circulation
Duration of Mesothelin-positive T cells in circulation
Time frame: 90 days post infusion
ORR
Overall response rate after administration
Time frame: 3 months post infusion
PFS
Progress Free Survival after administration
Time frame: 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)
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Time frame: 1 year post infusion