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NKG2D CAR-NK & Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05776355
Recruitment Status : Recruiting
First Posted : March 20, 2023
Last Update Posted : March 28, 2023
Sponsor:
Information provided by (Responsible Party):
Hangzhou Cheetah Cell Therapeutics Co., Ltd

Study Description
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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
Ovarian Cancer Biological: NKG2D CAR-NK Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : March 2023
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ovarian cancer Biological: NKG2D CAR-NK
Lymphodepleting chemotherapy followed by NKG2D CAR-NK infusion


Outcome Measures
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Primary Outcome Measures :
  1. DLT [ Time Frame: 28 days ]
    Dose-Limiting Toxicity

  2. MTD [ Time Frame: 28 days ]
    Maximal Tolerable Dose


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05776355


Contacts
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Contact: Zhu JianQing, MD 571-88128118 ext 86 zjq-hz@126.com

Locations
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China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China
Contact: Zhu JianQing, MD    571-88128118 ext 86    zjq-hz@126.com   
Sponsors and Collaborators
Hangzhou Cheetah Cell Therapeutics Co., Ltd
Investigators
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Principal Investigator: Zhu JianQing, MD Zhejiang Cancer Hospital
More Information
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Responsible Party: Hangzhou Cheetah Cell Therapeutics Co., Ltd
ClinicalTrials.gov Identifier: NCT05776355    
Other Study ID Numbers: IRB-2022-674
First Posted: March 20, 2023    Key Record Dates
Last Update Posted: March 28, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type