Intervention of CAR-T Against Cervical Cancer (NCT03356795) | Clinical Trial Compass
UnknownPhase 1/2
Intervention of CAR-T Against Cervical Cancer
China20 participantsStarted 2017-11-15
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexFEMALE
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Inclusion criteria
✓. Patients with stage III, IV or relapsed cervical cancer confirmed by histology and biopsy.
✓. Age: ≥ 18 years and ≤ 70 years.
✓. 4 weeks at least since last chemotherapy or radiotherapy and 2 weeks at least since last systemic steroid hormone and other immunosuppressive therapy.
✓. Side Effects of Chemotherapy have subsided.
✓. GD2, PSMA, Muc1, Mesothelin or other markers is expressed high (above 2+) in malignancy tissues by immuno-histochemical or flow cytometry.
✓. Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
✓. Expected survival ≥ 12 weeks.
✓. Initial hematopoietic reconstitution with
Exclusion criteria
✕. Airway obstruction caused by tumor.
✕. History of epilepsy or other central nervous system diseases.
✕. Patients who require systemic corticosteroid or other immunosuppressive therapy.
✕. History of prolonged or serious heart disease during QT.
✕. history of serious cyclophosphamide toxicity.
✕
What they're measuring
1
Safety of CART cells in patients using CTCAE version 4.0 standard to evaluate the level of adverse events