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Trial Title:
NKG2D CAR-NK & Ovarian Cancer
NCT ID:
NCT05776355
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Conditions: Keywords:
CAR-NK
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
NKG2D CAR-NK
Description:
Lymphodepleting chemotherapy followed by NKG2D CAR-NK infusion
Arm group label:
Ovarian cancer
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 18 years and older
2. Histologically or cytologically confirmed diagnosis of epithelial ovarian cancer
3. Documented platinum resistant epithelial ovarian cancer with at least 1 measurable
lesion
4. ECOG performance status of 0-2
5. 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
6. Negative urine or serum pregnancy test within 7 days prior to treatment for women of
childbearing age
7. Life expectancy ≥ 12 weeks from the time of enrollment
8. All patients must have the ability to understand and willingness to sign a written
informed consent form (ICF).
Exclusion Criteria:
1. Patients with history of other active malignancy within 1 year prior to enrollment;
2. 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;
3. 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;
4. Patients with immunologic deficiency or autoimmune diseases;
5. 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;
6. Patients who are breastfeeding or pregnant;
7. Patients, who in the opinion of the investigator, may not be able to comply with the
monitoring requirements of the study;
8. Patients participated in another investigation treatment study 4 weeks prior to
enrollment.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhu JianQing, MD
Phone:
571-88128118
Phone ext:
86
Email:
zjq-hz@126.com
Start date:
March 2023
Completion date:
September 2024
Lead sponsor:
Agency:
Hangzhou Cheetah Cell Therapeutics Co., Ltd
Agency class:
Other
Source:
Hangzhou Cheetah Cell Therapeutics Co., Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05776355
