Clinical trial · Interventional
The Fourth Generation CART-cell Therapy for Refractory-Relapsed Ovarian Cancer
The Clinical Research of Fourth Generation CART-cell Therapy in Refractory-Relapsed Ovarian Cancer
NCT03814447CI-TRIAL-00053197unknownEarly 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)
The goal of this clinical trial is to study the safety and feasibility of anti- Mesothelin Chimeric Antigen Receptor T-Cell (MESO CAR-T cells) therapy for Refractory-Relapsed 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 |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anti- MESO CAR-T cells | Drug | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- anti- MESO CAR-T cells
- description
- The subjects in this arm will receive Cyclophosphamide 300mg/m2/d and Fludarabine 30mg/m2/d d-4\~-2. Then anti- MESO CAR-T cells will be injected by a dose of 5×106/kg once at d1(rang from d1-3).
- interventionNames
- Drug: anti- MESO CAR-T cells
- Drug: Fludarabine
- Drug: Cyclophosphamide
Primary outcomes (1)
- measure
- Adverse events (AEs) and Serious adverse event (SAEs)
- timeFrame
- 1 year post infusion
- description
- Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.03
Secondary outcomes (7)
- measure
- Cmax
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histopathologically confirmed ovarian cancer; 2. 18-75 Years Old, female; 3. Expected survival \> 12 weeks; 4. Eastern Cooperative Oncology Group (ECOG) score 0-2; 5. Patients who have previously been treated with second- line or above standard treatment are failed (progress in treatment or recurrence within 6 months after discontinuation of treatment); 6. According to the Immune-Modified Response Evaluation Criteria In Solid Tumors (imRECIST) , there should be at least one measurable tumor foci; 7. Positive expression of Mesothelin in tumor tissue; 8. Creatinine ≤ 1.5×ULN or creatinine clearance ≥ 60ml / min; 9. alanine aminotransferase and aspartate aminotransferase ≤ 2.5×ULN , such as with liver metastasis, ≤ 5×ULN; 10. Total bilirubin ≤ 2×ULN; 11. Hemoglobin≥90g/L(No blood transfusion within 14 days); 12. Absolute value of neutrophils ≥1.5×10\^9/L; 13. Absolute counting of lymphocytes \>0.7×10\^9/L; 14. Counting of Platelet≥80×10\^9/L; 15. The venous access required for collection can be established without contraindications for leukocyte collection; 16. Able to understand and sign the Informed Consent Document. Exclusion Criteria: 1. Accompanied by other uncontrolled malignant tumors; 2. Active hepatitis B, hepatitis C, syphilis, HIV infection; 3. Insufficient function of important organs (heart, lung); 4. Any other uncontrolled active disease that impedes participation in the trial; 5. Any affairs could affect the safety of the subjects or purpose this trial; 6. Pregnant or lactating women, or patients who plan to be pregnancy during or after treatment; 7. There are active or uncontrollable infections (except simple urinary tract infections or upper respiratory tract infections) that require systemic therapy within 14 days or 14 days prior to enrollment; 8. The investigator believes that it is not appropriate to participate in the trial; 9. Received CAR-T treatment or other gene therapies before enrollment; Subjects suffering disease affect the understanding of informed consent or unable to comply with study; Unwilling or unable to comply with study requirements.
References
Publications (0)
Data not yet available
No reference posted for this study.