NCT03393962Enrolling by invitationPhase 1/2
Intervention of Ovarian Cancer With Antigen-specific Engineered Immune Effectors
Interventional Treatment of Ovarian Cancer With Cancer Antigen-specific Engineered Immune Effector T Lymphocytes (OC-EIEs)
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 28 Dec 2017
- Start date
- 1 Dec 2025
- Primary completion date
- 31 Jan 2028
- Lead sponsor
- Shenzhen Geno-Immune Medical Institute
- Diseases
- Ovarian cancer, Childhood cancers
- NCT number
- NCT03393962
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 20
- From 1 Dec 2025 to the primary completion date, 31 Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- Patients with ovarian tumors with low malignant potential (i.e. borderline tumors);
- Serious active infection requiring i.v. antibiotics
- Subject infected with HCV (HCV antibody positive), or HIV (HIV antibody positive),Treponema pallidum antibody positive or TB culture positive.
Lab values
- 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);
- 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.
Other
- Pregnant or lactating females.
Who the study is looking for
- 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.
- Human immunodeficiency virus (HIV) and hepatitis C virus (HCV) test negative.
Age in the registry: 10 years to 80 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shenzhen Geno-immune Medical Institute Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.