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NKG2D CAR-NK & Ovarian Cancer

Sponsor
Hangzhou Cheetah Cell Therapeutics Co., Ltd (Other)
Overall Status
Recruiting
CT.gov ID
NCT05776355
Collaborator
(none)
18
Enrollment
1
Location
1
Arm
18.1
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: NKG2D CAR-NK
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
18 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
NKG2D CAR-NK Cell Therapy for Patients With Platinum-Resistant Recurrent Ovarian Cancer
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ovarian cancer

Biological: NKG2D CAR-NK
Lymphodepleting chemotherapy followed by NKG2D CAR-NK infusion

Outcome Measures

Primary Outcome Measures

  1. DLT [28 days]

    Dose-Limiting Toxicity

  2. MTD [28 days]

    Maximal Tolerable Dose

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhejiang Cancer Hospital Hangzhou Zhejiang China

Sponsors and Collaborators

  • Hangzhou Cheetah Cell Therapeutics Co., Ltd

Investigators

  • Principal Investigator: Zhu JianQing, MD, Zhejiang Cancer Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hangzhou Cheetah Cell Therapeutics Co., Ltd
ClinicalTrials.gov Identifier:
NCT05776355
Other Study ID Numbers:
  • IRB-2022-674
First Posted:
Mar 20, 2023
Last Update Posted:
Mar 28, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hangzhou Cheetah Cell Therapeutics Co., Ltd
CAR-NK
Additional relevant MeSH terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial

Study Results

No Results Posted as of Mar 28, 2023