Clinical trial · Interventional
Intervention of CAR-T Against Cervical Cancer
Multicenter Trial of Chimeric Antigen Receptor-Modified T Cells (CAR-T Cells) in the Treatment of Cervical Cancer
NCT03356795CI-TRIAL-00123503terminatedPhase 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)
The purpose of this clinical trial is to assess the feasibility, safety and efficacy of CAR T cells immunotherapy in patients who have GD2, PSMA, Muc1, Mesothelin or other markers positive cervical cancer. Another goal of the study is to learn more about the persistence and function of CAR T cells in the body.
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 |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cervical cancer-specific CAR-T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cervical cancer-specific CAR-T cells
- description
- Peripheral blood mononuclear cells (PBMCs) of patients who have GD2, PSMA, Muc1 or Mesothelin positive cervical cancer will be obtained through apheresis, and T cells will be activated and modified to cervical cancer-specific CAR-T cells.
- interventionNames
- Biological: Cervical cancer-specific CAR-T cells
Primary outcomes (1)
- measure
- Safety of CART cells in patients using CTCAE version 4.0 standard to evaluate the level of adverse events
- timeFrame
- 3 months
- description
- Physiological parameter (measuring cytokine response)
Secondary outcomes (2)
- measure
- Persistence and proliferation of CART cells in patients
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with stage III, IV or relapsed cervical cancer confirmed by histology and biopsy. 2. Age: ≥ 18 years and ≤ 70 years. 3. 4 weeks at least since last chemotherapy or radiotherapy and 2 weeks at least since last systemic steroid hormone and other immunosuppressive therapy. 4. Side Effects of Chemotherapy have subsided. 5. GD2, PSMA, Muc1, Mesothelin or other markers is expressed high (above 2+) in malignancy tissues by immuno-histochemical or flow cytometry. 6. Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1. 7. Expected survival ≥ 12 weeks. 8. Initial hematopoietic reconstitution with * neutrophils (ANC) ≥ 1×10\^6/L; * platelet (PLT) ≥ 1×10\^8/L. 9. Proper renal and hepatic functions (ULN denotes "upper limit of normal range") with * serum creatinine ≤ 2×ULN; * serum bilirubin ≤ 3×ULN; * AST/ALT ≤ 2.5×ULN. 10. Oxygen saturation ≥ 90%. 11. Written, informed consent obtained prior to any study-specific procedures. Exclusion Criteria: 1. Airway obstruction caused by tumor. 2. History of epilepsy or other central nervous system diseases. 3. Patients who require systemic corticosteroid or other immunosuppressive therapy. 4. History of prolonged or serious heart disease during QT. 5. history of serious cyclophosphamide toxicity. 6. Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in this study. 7. Inadequate liver and renal function with * serum creatinine \> 1.5 mg/dl; * serum (total) bilirubin \> 2.0 mg/dl; * AST \& ALT \> 3 x ULN. 8. Pregnant or lactating females. 9. Serious active infection during screening. 10. Active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection or uncontrolled infection. 11. Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.
References
Publications (0)
Data not yet available
No reference posted for this study.