RecruitingPhase 1Phase 2NCT03184753

Genetically Modified T Cells Against Ovarian Cancer

Innovative Treatment of Ovarian Cancer Based on Immunogene-modified T Cells (IgT)

Sponsor

Shenzhen Geno-Immune Medical Institute

Enrollment

100 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer

Summary

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

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 65 Years

Inclusion Criteria14

Written, informed consent obtained prior to any study-specific procedures.
Female patients ≥ 20 years.
Eastern Cooperative Oncology Group (ECOG) PS of 0, 1 or 2.
Life expectancy ≥ 3 months.
Able to comply with the protocol.
Histologically confirmed and documented high risk International Federation of Gynecology and Obstetrics (FIGO): Stage III-IV.
Complete remission after salvage treatment for first recurrence.
Not pregnant, and on appropriate birth control if of childbearing potential.
Adequate bone marrow reserve with ·absolute neutrophil count (ANC) ≥ 1000/mm3.
·Platelets ≥100,000/mm3.
Adequate renal and hepatic function with ·Serum creatinine ≤ 2 x upper limit of normal (ULN). ·Serum bilirubin ≤ 2 x ULN.
aspartate aminotransferase (AST)/ALT ≤ 2 x ULN.
Alkaline phosphatase ≤ 5 x ULN.
Serum bilirubin. 2.0 is acceptable in the setting of known Gilbert's syndrome.

Exclusion Criteria16

Patients with:
Non-epithelial ovarian cancer.
Ovarian tumors with low malignant potential (i.e. borderline tumors).
Synchronous primary endometrial carcinoma and ovarian cancer. 2.Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure (prior, current or planned treatment).
Previous experience of gene-engineered T cell therapy 4.Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in this study.
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. 7.Inadequate bone marrow function:
·Absolute neutrophil count \< 1.0 x 109/L.
Platelet count \< 100 x 109/L.
Hb \< 9 g/dL. 8. Inadequate liver and renal function:
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 (or \> 5 x ULN in case of liver metastases or \> 10 x ULN in case of bone metastases).
Serum creatinine \>2.0 mg/dl (\> 177 μmol/L).
Urine dipstick for protein uria should be \< 2+. Patients with ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo 24 hour urine collection and must demonstrate \< 1 g of protein/24 hr.
\. Serious active infection requiring i.v. antibiotics at during screening. 10. Subject infected with HIV (HIV antibody positive), Treponema pallidum antibody positive or TB culture positive.