Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 65Years
FEMALE
NCT03184753

Genetically Modified T Cells Against Ovarian Cancer

Led by Shenzhen Geno-Immune Medical Institute · Updated on 2025-09-08

100

Participants Needed

1

Research Sites

243 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The primary objectives are to evaluate the safety and efficacy of infusion of autologous ovarian cancer immunogene-modified T cells (OC-IgT cells).

CONDITIONS

Official Title

Genetically Modified T Cells Against Ovarian Cancer

Who Can Participate

Age: 18Years - 65Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Written, informed consent obtained prior to any study-specific procedures.
  • Female patients aged 20 years or older.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Life expectancy of 3 months or more.
  • Able to follow the study protocol.
  • Histologically confirmed high-risk ovarian cancer, International Federation of Gynecology and Obstetrics (FIGO) Stage III-IV.
  • Complete remission after salvage treatment for first recurrence.
  • Not pregnant and using appropriate birth control if able to bear children.
  • Adequate bone marrow reserve with absolute neutrophil count (ANC) of 1000/mm3 or higher.
  • Platelet count of 100,000/mm3 or higher.
  • Adequate kidney and liver function with serum creatinine up to 2 times the upper limit of normal (ULN).
  • Serum bilirubin up to 2 times ULN (2.0 acceptable for Gilbert's syndrome).
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) up to 2 times ULN.
  • Alkaline phosphatase up to 5 times ULN.
Not Eligible

You will not qualify if you...

  • Non-epithelial ovarian cancer.
  • Ovarian tumors with low malignant potential (borderline tumors).
  • Simultaneous primary endometrial carcinoma and ovarian cancer.
  • Evidence of unexplained abdominal free air.
  • Previous gene-engineered T cell therapy.
  • Treatment with another investigational drug or prior participation in this study within 28 days before Day 0.
  • Minor surgery within 2 days before Day 0.
  • Pregnant or breastfeeding females.
  • Inadequate bone marrow function: absolute neutrophil count below 1.0 x 10^9/L, platelet count below 100 x 10^9/L, hemoglobin below 9 g/dL.
  • Inadequate liver and kidney function: serum bilirubin above 1.5 times ULN, AST and ALT above 2.5 times ULN (or above 5 times ULN with liver metastases), alkaline phosphatase above 2.5 times ULN (or above 5 or 10 times ULN with metastases), serum creatinine above 2.0 mg/dL.
  • Proteinuria of 2+ or more on dipstick urinalysis without confirmed low proteinuria on 24-hour collection.
  • Serious active infection requiring intravenous antibiotics during screening.
  • Infection with HIV, Treponema pallidum, or positive tuberculosis culture.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, China, 518000

Actively Recruiting

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Research Team

L

Lung-Ji Chang, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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