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

Status

Recruiting

Conditions

Intervention / Treatment

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

  • China
    • 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:

  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.

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
Biological: NKG2D CAR-NK
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.

Sponsor

Hangzhou Cheetah Cell Therapeutics Co., Ltd

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

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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