search
Back to results

NKG2D CAR-NK & Ovarian Cancer

Primary Purpose

Ovarian Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
NKG2D CAR-NK
Sponsored by
Hangzhou Cheetah Cell Therapeutics Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring CAR-NK

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ovarian cancer

Arm Description

Outcomes

Primary Outcome Measures

DLT
Dose-Limiting Toxicity
MTD
Maximal Tolerable Dose

Secondary Outcome Measures

Full Information

First Posted
March 8, 2023
Last Updated
March 26, 2023
Sponsor
Hangzhou Cheetah Cell Therapeutics Co., Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT05776355
Brief Title
NKG2D CAR-NK & Ovarian Cancer
Official Title
NKG2D CAR-NK Cell Therapy for Patients With Platinum-Resistant Recurrent Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hangzhou Cheetah Cell Therapeutics Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
CAR-NK

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ovarian cancer
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
NKG2D CAR-NK
Intervention Description
Lymphodepleting chemotherapy followed by NKG2D CAR-NK infusion
Primary Outcome Measure Information:
Title
DLT
Description
Dose-Limiting Toxicity
Time Frame
28 days
Title
MTD
Description
Maximal Tolerable Dose
Time Frame
28 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhu JianQing, MD
Phone
571-88128118
Ext
86
Email
zjq-hz@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhu JianQing, MD
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhu JianQing, MD
Phone
571-88128118
Ext
86
Email
zjq-hz@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

NKG2D CAR-NK & Ovarian Cancer

We'll reach out to this number within 24 hrs