- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05776355
NKG2D CAR-NK & Ovarian Cancer
March 26, 2023 updated by: Hangzhou Cheetah Cell Therapeutics Co., Ltd
NKG2D CAR-NK Cell Therapy for Patients With Platinum-Resistant Recurrent Ovarian Cancer
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhu JianQing, MD
- Phone Number: 86 571-88128118
- Email: zjq-hz@126.com
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China
- Recruiting
- Zhejiang Cancer Hospital
-
Contact:
- Zhu JianQing, MD
- Phone Number: 86 571-88128118
- Email: zjq-hz@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ovarian cancer
|
Lymphodepleting chemotherapy followed by NKG2D CAR-NK infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
DLT
Time Frame: 28 days
|
Dose-Limiting Toxicity
|
28 days
|
MTD
Time Frame: 28 days
|
Maximal Tolerable Dose
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Zhu JianQing, MD, Zhejiang Cancer Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 1, 2023
Primary Completion (Anticipated)
April 1, 2024
Study Completion (Anticipated)
September 1, 2024
Study Registration Dates
First Submitted
March 8, 2023
First Submitted That Met QC Criteria
March 8, 2023
First Posted (Actual)
March 20, 2023
Study Record Updates
Last Update Posted (Actual)
March 28, 2023
Last Update Submitted That Met QC Criteria
March 26, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- IRB-2022-674
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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