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Study of Anti-Mesothelin Car NK Cells in Epithelial Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT03692637
Recruitment Status : Not yet recruiting
First Posted : October 2, 2018
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Allife Medical Science and Technology Co., Ltd.

Brief Summary:
This is a single centre、single arm、open-label,to investigate the safety and efficacy of anti-Mesothelin Car NK Cells With Epithelial ovarian cancer

Condition or disease Intervention/treatment Phase
Epithelial Ovarian Cancer Biological: anti-Mesothelin Car NK Cells Early Phase 1

Detailed Description:
Ovarian cancer ranks second in gynecologic malignancies, but mortality ranks first. It is one of the most serious malignant tumors that threaten women's lives. It is urgent to explore new treatment methods, such as introduction. Tumor immunotherapy strategies to improve treatment outcomes and patient quality of life. Car is a group of fusion proteins composed of multiple parts, including antigen recognition region, transmembrane region, and NK cell stimulation region. NK cells are naive immune cells that are not restricted by MHI and can be activated without additional co-stimulatory regions. After activation, granulin-B and γ-interferon are released, thereby inducing apoptosis of tumor cells and lysis of tumor cells. The study will follow a 3 + 3 design of dose- escalating cohorts. After a patient enrolls, leukapheresis will be performed to obtain peripheral blood mononuclearcells which will be sent to a manufacturing site to produce anti-Mesothelin Car NK cells. The cells will then be returned to the investigational site and, after a standard chemotherapy based conditioning regimen, will be administered to the patient. Treated patients will undergo serial measurements of safety, tolerability and response.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study on the Safety and Efficacy of Anti-Mesothelin Car NK Cells With Epithelial Ovarian Cancer
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: anti-Mesothelin Car NK Cells
Total dose of 0.5-3 million /kg cells will be administered at day0
Biological: anti-Mesothelin Car NK Cells
anti-Mesothelin Car NK Cells injection




Primary Outcome Measures :
  1. Occurrence of treatment related adverse events as assessed by CTCAE v4.0 [ Time Frame: Day 3-Year 2 after injection ]
    defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events that are possibly, likely, or definitely related to study treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Mesothelin-positive patients with stage II-IV epithelial ovarian cancer.(Mesothelin expression ≥50% of tumor cells)(Patients with recurrence are not excluded)
  2. Male or female, 18 to 70 years old (including 18 and 70 years old)
  3. The excepted survival ≥ 6 months,Karnofsky activity function status score ≥ 60 points
  4. there are measurable lesions according to the RECIST 1.1 standard.
  5. Bone marrow function (blood routine) satisfies: the number of neutrophils > 1×109/L platelet > 7.5×109/L; hemoglobin > 90 g/L; total bilirubin < 2.0 mg/dL; creatinine < 1.5 times the upper limit; albumin < 2 g/L; ALT or AST < 5 times the upper limit; creatinine clearance rateby Cockcroft-Gault formula< 40 mL/min
  6. Coagulation parameters: INR ≤ 1.5, PTT < 1.2 times the upper limt
  7. Patients did not receive any chemotherapy, radiotherapy, immunotherapy (such as immunosuppressive drugs PD-1, PDL-1) or other anticancer treatment 2-4 weeks before admission, and the treatment-related toxicity reaction ≤1 level prior to enrollment(except low toxicity lose hair for example)
  8. Venous channel is unobstructed, which can meet the needs of intravenous drip
  9. HIV test was negative; HBV and HCV were negative
  10. Voluntary informed consent is given, agree to follow the trial treatment and visit plan

Exclusion Criteria:

  1. Patients with hypertension (> 160/95 mmHg) are uncontrollable; coronary heart disease and angina pectoris are unstable (Canadian Cardiovascular Association Level II and above), or recurrent within 6 months
  2. Patients suffer from concurrent or central nervous system diseases
  3. Patients with severe autoimmune diseases or immunodeficiency diseases
  4. Patient's lung function has the following abnormalities: FEV (forced expiratory volume), < 30%; DLCO (diffusing capacity of lung for carbon monoxide) < 30%; oxygen saturation < 90%
  5. Patients treated with other immune cellular products (DC, CIK, T, NK, and Car T products with CD19 or other targets)
  6. Patients with Severe liver and kidney dysfunction
  7. Patients with Severe bacterial and viral infections
  8. Patients are pregnant or nursing
  9. Patients used corticosteroids within 4 weeks prior to enrollment(except patients with inhaled hormone)
  10. Patients participated in other clinical trials within 30 days.
  11. Patients had other conditions that were not appropriate for the group determined by the researchers.

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Responsible Party: Allife Medical Science and Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03692637     History of Changes
Other Study ID Numbers: Mesothelin Car NK-HNRM-01
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Carcinoma