Clinical trial · Interventional
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)
NCT03393962CI-TRIAL-00115616enrolling by invitationPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OC-EIEs | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OC-EIEs
- description
- Autologous ovarian cancer antigen-specific cytotoxic lymphocytes
- interventionNames
- Biological: OC-EIEs
Primary outcomes (1)
- measure
- Safety of OC-EIEs in patients using CTCAE version 4.0 standard to evaluate the level of adverse events
- timeFrame
- 6 months
- description
- percentage of patients with grade 3 or above adverse effect
Secondary outcomes (5)
- measure
- Expansion of OC-EIEs
- timeFrame
- 8 weeks.
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 10 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Written, informed consent obtained prior to any study-specific procedures. 2. Age older than 10 years. 3. Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1. 4. Expected survival ≥ 12 weeks. 5. Histologically confirmed and documented high risk International Federation of Gynecology and Obstetrics (FIGO): Stage II-IV. 6. Not pregnant, and on appropriate birth control of childbearing potential. 7. Initial hematopoietic reconstitution with * neutrophils (ANC) ≥ 1,000/mm\^3; * platelet (PLT) ≥ 100,000/mm\^3. 8. 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. 9. Human immunodeficiency virus (HIV) and hepatitis C virus (HCV) test negative. Exclusion Criteria: 1. Patients with ovarian tumors with low malignant potential (i.e. borderline tumors); 2. Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure (prior, current or planned treatment). 3. Prior treatment of any adoptive T cell therapy. 4. Current or recent treatment (within the 14-day period prior to Day 0) with any immune suppressive drug 5. Minor surgical procedures within 2 days prior to Day 0 (including central venous access device placement for chemotherapy administration, tumor biopsies, needle aspirations). 6. Pregnant or lactating females. 7. Inadequate bone marrow function with * absolute neutrophil count \< 1,000/mm\^3; * platelet count \< 100,000/mm\^3; * Hb \< 9 g/dL. 8. 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. 9. Serious active infection requiring i.v. antibiotics 10. Subject infected with HCV (HCV antibody positive), or HIV (HIV antibody positive),Treponema pallidum antibody positive or TB culture positive.
References
Publications (0)
Data not yet available
No reference posted for this study.