NKG2D CAR-NK & Ovarian Cancer

Study Overview
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Brief Summary
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This trial will explore the maximum tolerated dose （MTD）of NKG2D CAR-NK cells in the treatment of platinum-resistant, relapsed epithelial ovarian cancer in a dose-escalation manner, and observe the clinical safety and efficacy.

Official Title
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NKG2D CAR-NK Cell Therapy for Patients With Platinum-Resistant Recurrent Ovarian Cancer

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Biological: NKG2D CAR-NK


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years and older Histologically or cytologically confirmed diagnosis of epithelial ovarian cancer Documented platinum resistant epithelial ovarian cancer with at least 1 measurable lesion ECOG performance status of 0-2 Adequate organ function defined as: ANC≥1.5×109/L, PLT≥75×109/L, TBIL≤1.5×ULN, AST≤2.5×ULN, ALT≤2.5×ULN, Cr≤1.5×ULN Negative urine or serum pregnancy test within 7 days prior to treatment for women of childbearing age Life expectancy ≥ 12 weeks from the time of enrollment All patients must have the ability to understand and willingness to sign a written informed consent form (ICF). Exclusion Criteria: Patients with history of other active malignancy within 1 year prior to enrollment; Patients with central nervous system (CNS) metastases. History of any CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, any autoimmune disease with CNS involvement, posterior reversible encephalopathy syndrome, or cerebral edema; Patients with ongoing uncontrolled serious infection, clinically significant cardiac disease (i.e., symptomatic congestive heart failure, myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, uncontrolled cardiac arrhythmia), poorly controlled pulmonary disease (no clinically significant pleural effusion), or psychiatric illness/social situations that would limit compliance with study requirements within 12 months prior to enrollment; Patients with immunologic deficiency or autoimmune diseases; Known human immunodeficiency virus (HIV) seropositivity or active hepatitis B or C infection. A history of hepatitis B or C is permitted if the viral load is undetectable by quantitative assay; Patients who are breastfeeding or pregnant; Patients, who in the opinion of the investigator, may not be able to comply with the monitoring requirements of the study; Patients participated in another investigation treatment study 4 weeks prior to enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ovarian cancer<br> | Biological: NKG2D CAR-NK<br>* Lymphodepleting chemotherapy followed by NKG2D CAR-NK infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DLT | Dose-Limiting Toxicity | 28 days | 
| MTD | Maximal Tolerable Dose | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CAR-NK