NCT05776355

Brief Summary

This trial will explore the maximum tolerated dose （MTD）of NKG2D CAR-NK cells in the treatment of platinum-resistant, relapsed epithelial ovarian cancer in a dose-escalation manner, and observe the clinical safety and efficacy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable ovarian-cancer

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable ovarian-cancer

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 1, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 20, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

March 8, 2023

Last Update Submit

March 26, 2023

Conditions

Ovarian Cancer

Keywords

CAR-NK

Outcome Measures

Primary Outcomes (2)

  • DLT

    Dose-Limiting Toxicity

    28 days

  • MTD

    Maximal Tolerable Dose

    28 days

Study Arms (1)

Ovarian cancer

EXPERIMENTAL
Biological: NKG2D CAR-NK

Interventions

NKG2D CAR-NKBIOLOGICAL

Lymphodepleting chemotherapy followed by NKG2D CAR-NK infusion

Ovarian cancer

Eligibility Criteria

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

You may qualify if:

  • Age 18 years and older
  • Histologically or cytologically confirmed diagnosis of epithelial ovarian cancer
  • Documented platinum resistant epithelial ovarian cancer with at least 1 measurable lesion
  • ECOG performance status of 0-2
  • Adequate organ function defined as: ANC≥1.5×109/L, PLT≥75×109/L, TBIL≤1.5×ULN, AST≤2.5×ULN, ALT≤2.5×ULN, Cr≤1.5×ULN
  • Negative urine or serum pregnancy test within 7 days prior to treatment for women of childbearing age
  • Life expectancy ≥ 12 weeks from the time of enrollment
  • All patients must have the ability to understand and willingness to sign a written informed consent form (ICF).

You may not qualify if:

  • Patients with history of other active malignancy within 1 year prior to enrollment;
  • Patients with central nervous system (CNS) metastases. History of any CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, any autoimmune disease with CNS involvement, posterior reversible encephalopathy syndrome, or cerebral edema;
  • Patients with ongoing uncontrolled serious infection, clinically significant cardiac disease (i.e., symptomatic congestive heart failure, myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, uncontrolled cardiac arrhythmia), poorly controlled pulmonary disease (no clinically significant pleural effusion), or psychiatric illness/social situations that would limit compliance with study requirements within 12 months prior to enrollment;
  • Patients with immunologic deficiency or autoimmune diseases;
  • Known human immunodeficiency virus (HIV) seropositivity or active hepatitis B or C infection. A history of hepatitis B or C is permitted if the viral load is undetectable by quantitative assay;
  • Patients who are breastfeeding or pregnant;
  • Patients, who in the opinion of the investigator, may not be able to comply with the monitoring requirements of the study;
  • Patients participated in another investigation treatment study 4 weeks prior to enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Zhu JianQing, MD

    Zhejiang Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhu JianQing, MD

CONTACT

571-88128118zjq-hz@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2023

First Posted

March 20, 2023

Study Start

March 1, 2023

Primary Completion

April 1, 2024

Study Completion

September 1, 2024

Last Updated

March 28, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)