PD-1 Silent PSMA/PSCA Targeted CAR-T for the Treatment of Prostate Cancer
Prostate Cancer
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria: Evidence of metastatic disease in bone on bone scan, CT scan, and/or by MRI atany time following the initial diagnosis of prostate cancer; The corresponding antigens such as PSMA and PSCA/PDL1 were highly expressed; Male patients aged between 18 and 65; Karnofsky score ≥ 60, ECOG≤ 2; Important organ function as defined by the following: cardiac ejection fraction ≥ 50%; electrocardiogram showed no obvious abnormalities; creatinine clearance rate calculated by using Cockcroft- Gault formula ≥40ml/min ; ALT/AST≤ 3×the institution normal upper limit; total bilirubin ≤2.0mg/dl; coagulation function: PT/ APPT<2 ×the institution normal upper limit; SpO2 >92%; Blood: hemoglobin>80g/L, ANC ≥ 1, PLT ≥ 50×109/L; There is measurable target lesion; Voluntary informed consent is given; Exclusion Criteria: Immunosuppressive drugs or hormones were used a week before admission; Severe active infection; Human immunodeficiency virus (HIV) positive; Active hepatitis B or C infection; Past medical history of other malignancies. Not included: patients who have been cured at any time prior to the treatment of the skin basal or squamous cell carcinoma and cervical carcinoma in situ; the other tumor has not listed above, but has been used and only cured by surgery, without further treatment by other measures, the subjects of disease-free survival more than 5 years, can be included in the study; Patients participating in other clinical trials; The researchers thought the subjects were unfit for inclusion or unable to participate in or complete the study; Patients with congenital immunodeficiency; There is a history of myocardial infarction and serious arrhythmia within six months;
Sites / Locations
- The First Affiliated Hospital of Soochow UniversityRecruiting
Arms of the Study
Arm 1
Experimental
autologous T cells & cyclophosphamide
This is a phase I dose escalation study to assess the safety and tolerability using increasing doses of engineered autologous T cells PD-1 silent targeted to PSMA/PSMA administered one day after pretreatment with cyclophosphamide.