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

January 30, 2019 updated by: Allife Medical Science and Technology Co., Ltd.

Clinical Study on the Safety and Efficacy of Anti-Mesothelin Car NK Cells With Epithelial Ovarian Cancer

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 3-Year 2 after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allife Medical Science and Technology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2019

Primary Completion (ANTICIPATED)

November 1, 2020

Study Completion (ANTICIPATED)

November 1, 2021

Study Registration Dates

First Submitted

September 29, 2018

First Submitted That Met QC Criteria

September 29, 2018

First Posted (ACTUAL)

October 2, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 30, 2019

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mesothelin Car NK-HNRM-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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