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

Primary Purpose

Epithelial Ovarian Cancer

Status

Unknown status

Phase

Early Phase 1

Locations

Study Type

Interventional

Intervention

anti-Mesothelin Car NK Cells

About this trial

This is an interventional treatment trial for Epithelial Ovarian Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Mesothelin-positive patients with stage II-IV epithelial ovarian cancer.（Mesothelin expression ≥50% of tumor cells）（Patients with recurrence are not excluded）
Male or female, 18 to 70 years old (including 18 and 70 years old)
The excepted survival ≥ 6 months,Karnofsky activity function status score ≥ 60 points
there are measurable lesions according to the RECIST 1.1 standard.
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
Coagulation parameters: INR ≤ 1.5, PTT < 1.2 times the upper limt
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）
Venous channel is unobstructed, which can meet the needs of intravenous drip
HIV test was negative; HBV and HCV were negative
Voluntary informed consent is given, agree to follow the trial treatment and visit plan

Exclusion Criteria:

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
Patients suffer from concurrent or central nervous system diseases
Patients with severe autoimmune diseases or immunodeficiency diseases
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%
Patients treated with other immune cellular products (DC, CIK, T, NK, and Car T products with CD19 or other targets)
Patients with Severe liver and kidney dysfunction
Patients with Severe bacterial and viral infections
Patients are pregnant or nursing
Patients used corticosteroids within 4 weeks prior to enrollment(except patients with inhaled hormone)
Patients participated in other clinical trials within 30 days.
Patients had other conditions that were not appropriate for the group determined by the researchers.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

anti-Mesothelin Car NK Cells

Arm Description

Total dose of 0.5-3 million /kg cells will be administered at day0

Outcomes

Primary Outcome Measures

Occurrence of treatment related adverse events as assessed by CTCAE v4.0

defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events that are possibly, likely, or definitely related to study treatment

Secondary Outcome Measures

Full Information

NCT ID

NCT03692637

First Posted

September 29, 2018

Last Updated

January 30, 2019

Sponsor

Allife Medical Science and Technology Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03692637

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Unknown status

Study Start Date

March 2019 (Anticipated)

Primary Completion Date

November 2020 (Anticipated)

Study Completion Date

November 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Allife Medical Science and Technology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epithelial Ovarian Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

anti-Mesothelin Car NK Cells

Arm Type

Experimental

Arm Description

Total dose of 0.5-3 million /kg cells will be administered at day0

Intervention Type

Biological

Intervention Name(s)

anti-Mesothelin Car NK Cells

Intervention Description

anti-Mesothelin Car NK Cells injection

Primary Outcome Measure Information:

Title

Occurrence of treatment related adverse events as assessed by CTCAE v4.0

Description

defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events that are possibly, likely, or definitely related to study treatment

Time Frame

Day 3-Year 2 after injection

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Mesothelin-positive patients with stage II-IV epithelial ovarian cancer.（Mesothelin expression ≥50% of tumor cells）（Patients with recurrence are not excluded） Male or female, 18 to 70 years old (including 18 and 70 years old) The excepted survival ≥ 6 months,Karnofsky activity function status score ≥ 60 points there are measurable lesions according to the RECIST 1.1 standard. 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 Coagulation parameters: INR ≤ 1.5, PTT < 1.2 times the upper limt 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） Venous channel is unobstructed, which can meet the needs of intravenous drip HIV test was negative; HBV and HCV were negative Voluntary informed consent is given, agree to follow the trial treatment and visit plan Exclusion Criteria: 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 Patients suffer from concurrent or central nervous system diseases Patients with severe autoimmune diseases or immunodeficiency diseases 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% Patients treated with other immune cellular products (DC, CIK, T, NK, and Car T products with CD19 or other targets) Patients with Severe liver and kidney dysfunction Patients with Severe bacterial and viral infections Patients are pregnant or nursing Patients used corticosteroids within 4 weeks prior to enrollment(except patients with inhaled hormone) Patients participated in other clinical trials within 30 days. Patients had other conditions that were not appropriate for the group determined by the researchers.

12. IPD Sharing Statement

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

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