Clinical trial · Interventional
MESO-CAR T Cells Therapy for Relapsed and Refractory Ovarian Cancer
A Clinical Trial of MESO-CAR T Cells Therapy for Relapsed and Refractory Ovarian Cancer
NCT03799913CI-TRIAL-00038060unknownEarly 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 feasibility and efficacy of anti-MESO antigen receptors (CARs) T cell therapy for relapsed and refractory 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 | Biological | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- anti-MESO CAR-T cells
- description
- Administration with anti-MESO CAR-T cells in the MESO-positive ovarian cancer patients
- interventionNames
- Biological: anti-MESO CAR-T cells
- Drug: Fludarabine
- Drug: Cyclophosphamide
Primary outcomes (1)
- measure
- Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
- timeFrame
- 1 years post infusion
Secondary outcomes (4)
- measure
- Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm
- timeFrame
- 12 months post infusion
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18 to 70 Years Old, female; 2. Expected survival \> 12 weeks; 3. Clinical performance status of ECOG score 0-2; 4. Patients who have previously been treated with second- line or more lines of standard treatment are not effective (No remission or recurrence after remission); 5. At least one measurable tumor foci according to RECIST standard 1.1 ; 6. Positive Mesothelin expression in tumor tissues; 7. Creatinine ≤ 1.5×ULN; 8. ALT and AST ≤ 3×ULN; 9. Total bilirubin ≤ 2×ULN; 10. Hemoglobin≥90g/L; 11. Absolute counting of neutrophils≥1000uL ; 12. Absolute counting of lymphocytes\>0.7×10\^9/L; 13. Counting of Platelet≥75000/uL; 14. The venous access required for collection can be established without contraindications for leukocyte collection; 15. 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. Suffering severe cardiovascular or respiratory disease; 4. Any other diseases could affect the outcome of this trial; 5. Any affairs could affect the safety of the subjects or outcome of 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 14 days or 14 days prior to assignment; 8. Patients who are accounted by researchers to be not appropriate for this test; 9. Received CAR-T treatment or other gene therapies before assignment; 10. Subject suffering disease affects the understanding of informed consent or comply with study protocol.
References
Publications (0)
Data not yet available
No reference posted for this study.