NCT03692637

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Mar 2019

Typical duration for early_phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 2, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

January 31, 2019

Status Verified

September 1, 2018

Enrollment Period

1.7 years

First QC Date

September 29, 2018

Last Update Submit

January 30, 2019

Conditions

Epithelial Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

    Day 3-Year 2 after injection

Study Arms (1)

anti-Mesothelin Car NK Cells

EXPERIMENTAL

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

Biological: anti-Mesothelin Car NK Cells

Interventions

anti-Mesothelin Car NK CellsBIOLOGICAL

anti-Mesothelin Car NK Cells injection

anti-Mesothelin Car NK Cells

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2018

First Posted

October 2, 2018

Study Start

March 1, 2019

Primary Completion

November 1, 2020

Study Completion

November 1, 2021

Last Updated

January 31, 2019

Record last verified: 2018-09