NCT03393962

Brief Summary

This is a single-arm, open-label, phase I/II trial to evaluate the safety and efficacy of ovarian cancer-specific, engineered immune effectors (OC-EIEs) in women.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 ovarian-cancer

Timeline
32mo left

Started Dec 2025

Geographic Reach
1 country

3 active sites

Status
enrolling by invitation

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 Progress15%
Dec 2025Dec 2028

First Submitted

Initial submission to the registry

December 28, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 9, 2018

Completed
7.9 years until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2028

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

December 28, 2017

Last Update Submit

April 21, 2026

Conditions

Ovarian Cancer

Keywords

Ovarian cancerCytotoxic lymphocyteCancer specific antigen

Outcome Measures

Primary Outcomes (1)

  • Safety of OC-EIEs in patients using CTCAE version 4.0 standard to evaluate the level of adverse events

    percentage of patients with grade 3 or above adverse effect

    6 months

Secondary Outcomes (5)

  • Expansion of OC-EIEs

    8 weeks.

  • percentage of complete response

    1 year

  • percentage of partial response

    1 year

  • percentage of stable disease

    1 year

  • percentage of progressive disease

    1 year

Study Arms (1)

OC-EIEs

EXPERIMENTAL

Autologous ovarian cancer antigen-specific cytotoxic lymphocytes

Biological: OC-EIEs

Interventions

OC-EIEsBIOLOGICAL

2 to 4 infusions, once a week, 0.1\~4x10\^6 CTLs/kg; injection via IV, abdominal cavity or intrastumoral.

OC-EIEs

Eligibility Criteria

Age10 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Written, informed consent obtained prior to any study-specific procedures.
  • Age older than 10 years.
  • Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
  • Expected survival ≥ 12 weeks.
  • Histologically confirmed and documented high risk International Federation of Gynecology and Obstetrics (FIGO): Stage II-IV.
  • Not pregnant, and on appropriate birth control of childbearing potential.
  • Initial hematopoietic reconstitution with
  • neutrophils (ANC) ≥ 1,000/mm\^3;
  • platelet (PLT) ≥ 100,000/mm\^3.
  • Proper renal and hepatic functions (ULN denotes "upper limit of normal range") with
  • serum creatinine ≤ 2×ULN;
  • serum bilirubin ≤ 2×ULN;
  • AST/ALT ≤ 2×ULN;
  • ALKP ≤ 5×ULN;
  • serum bilirubin. 2.0 is acceptable in the setting of known Gilbert's syndrome.
  • +1 more criteria

You may not qualify if:

  • Patients with ovarian tumors with low malignant potential (i.e. borderline tumors);
  • Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure (prior, current or planned treatment).
  • Prior treatment of any adoptive T cell therapy.
  • Current or recent treatment (within the 14-day period prior to Day 0) with any immune suppressive drug
  • Minor surgical procedures within 2 days prior to Day 0 (including central venous access device placement for chemotherapy administration, tumor biopsies, needle aspirations).
  • Pregnant or lactating females.
  • Inadequate bone marrow function with
  • absolute neutrophil count \< 1,000/mm\^3;
  • platelet count \< 100,000/mm\^3;
  • Hb \< 9 g/dL.
  • Inadequate liver and renal function with
  • serum (total) bilirubin \> 1.5 x ULN;
  • AST \& ALT \> 2.5 x ULN (\> 5 x ULN in patients with liver metastases);
  • alkaline phosphatase \> 2.5 x ULN;
  • serum creatinine \>2.0 mg/dl (\> 177 μmol/L);
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Jinshazhou Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, 510415, China

Location

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, 518000, China

Location

Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center

Kunming, Yunnan, 650000, China

Location

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

  • Lung-Ji Chang, PhD

    Shenzhen Geno-Immune Medical Institute

    PRINCIPAL INVESTIGATOR

  • Qichun Cai, MD

    Jinshazhou Hospital of Guangzhou University of Chinese Medicine

    STUDY DIRECTOR

  • Xun Lai, MD

    Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President

Study Record Dates

First Submitted

December 28, 2017

First Posted

January 9, 2018

Study Start

December 1, 2025

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)