NKG2D CAR-NK & Ovarian Cancer

NCT ID: NCT05776355

Last Updated: 2023-03-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-31
• Study Completion Date: 2024-09-30

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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ovarian cancer

Group Type: EXPERIMENTAL

NKG2D CAR-NK

Intervention Type: BIOLOGICAL

Lymphodepleting chemotherapy followed by NKG2D CAR-NK infusion

Interventions

NKG2D CAR-NK

Lymphodepleting chemotherapy followed by NKG2D CAR-NK infusion

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hangzhou Cheetah Cell Therapeutics Co., Ltd

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhu JianQing, MD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhu JianQing, MD

Role: CONTACT

zjq-hz@126.com

571-88128118 ext. 86

Facility Contacts

Zhu JianQing, MD

Role: primary

zjq-hz@126.com

571-88128118 ext. 86

Other Identifiers

IRB-2022-674

Identifier Type: -

Identifier Source: org_study_id