Clinical Trials /

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

NCT03692637

Description:

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

Related Conditions:
  • Malignant Ovarian Epithelial Tumor
Recruiting Status:

Not yet recruiting

Phase:

Early Phase 1

URL:

https://clinicaltrials.gov/show/NCT03692637

Trial Eligibility

Document

Title

  • Brief Title: Study of Anti-Mesothelin Car NK Cells in Epithelial Ovarian Cancer
  • Official Title: Clinical Study on the Safety and Efficacy of Anti-Mesothelin Car NK Cells With Epithelial Ovarian Cancer

Clinical Trial IDs

  • ORG STUDY ID: Mesothelin Car NK-HNRM-01
  • NCT ID: NCT03692637

Conditions

  • Epithelial Ovarian Cancer

Interventions

DrugSynonymsArms
anti-Mesothelin Car NK Cellsanti-Mesothelin Car NK Cells

Purpose

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

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.

Trial Arms

NameTypeDescriptionInterventions
anti-Mesothelin Car NK CellsExperimentalTotal dose of 0.5-3 million /kg cells will be administered at day0
  • anti-Mesothelin Car NK Cells

Eligibility 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.
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

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

Details

Phase:Early Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Allife Medical Science and Technology Co., Ltd.

Last Updated

January 31, 2019