Clinical trial · Interventional
Study of Anti-Mesothelin Car NK Cells in Epithelial Ovarian Cancer
Clinical Study on the Safety and Efficacy of Anti-Mesothelin Car NK Cells With Epithelial Ovarian Cancer
NCT03692637CI-TRIAL-00036840unknownEarly Phase 1ClinicalTrials.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 centre、single arm、open-label,to investigate the safety and efficacy of anti-Mesothelin Car NK Cells With Epithelial ovarian cancer
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 |
|---|---|---|---|
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anti-Mesothelin Car NK Cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- anti-Mesothelin Car NK Cells
- description
- Total dose of 0.5-3 million /kg cells will be administered at day0
- interventionNames
- Biological: anti-Mesothelin Car NK Cells
Primary outcomes (1)
- measure
- Occurrence of treatment related adverse events as assessed by CTCAE v4.0
- timeFrame
- Day 3-Year 2 after injection
- description
- defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events that are possibly, likely, or definitely related to study treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Mesothelin-positive patients with stage II-IV epithelial ovarian cancer.(Mesothelin expression ≥50% of tumor cells)(Patients with recurrence are not excluded) 2. Male or female, 18 to 70 years old (including 18 and 70 years old) 3. The excepted survival ≥ 6 months,Karnofsky activity function status score ≥ 60 points 4. there are measurable lesions according to the RECIST 1.1 standard. 5. Bone marrow function (blood routine) satisfies: the number of neutrophils \> 1×109/L platelet \> 7.5×109/L; hemoglobin \> 90 g/L; total bilirubin \< 2.0 mg/dL; creatinine \< 1.5 times the upper limit; albumin \< 2 g/L; ALT or AST \< 5 times the upper limit; creatinine clearance rateby Cockcroft-Gault formula\< 40 mL/min 6. Coagulation parameters: INR ≤ 1.5, PTT \< 1.2 times the upper limt 7. Patients did not receive any chemotherapy, radiotherapy, immunotherapy (such as immunosuppressive drugs PD-1, PDL-1) or other anticancer treatment 2-4 weeks before admission, and the treatment-related toxicity reaction ≤1 level prior to enrollment(except low toxicity lose hair for example) 8. Venous channel is unobstructed, which can meet the needs of intravenous drip 9. HIV test was negative; HBV and HCV were negative 10. Voluntary informed consent is given, agree to follow the trial treatment and visit plan Exclusion Criteria: 1. Patients with hypertension (\> 160/95 mmHg) are uncontrollable; coronary heart disease and angina pectoris are unstable (Canadian Cardiovascular Association Level II and above), or recurrent within 6 months 2. Patients suffer from concurrent or central nervous system diseases 3. Patients with severe autoimmune diseases or immunodeficiency diseases 4. Patient's lung function has the following abnormalities: FEV (forced expiratory volume), \< 30%; DLCO (diffusing capacity of lung for carbon monoxide) \< 30%; oxygen saturation \< 90% 5. Patients treated with other immune cellular products (DC, CIK, T, NK, and Car T products with CD19 or other targets) 6. Patients with Severe liver and kidney dysfunction 7. Patients with Severe bacterial and viral infections 8. Patients are pregnant or nursing 9. Patients used corticosteroids within 4 weeks prior to enrollment(except patients with inhaled hormone) 10. Patients participated in other clinical trials within 30 days. 11. Patients had other conditions that were not appropriate for the group determined by the researchers.
References
Publications (0)
Data not yet available
No reference posted for this study.