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Taking people in ChinaPhase 1

Tests PSMA-targeted CAR-T cell therapy for advanced prostate cancer

Tests modified immune cells against prostate cancer in adults with castration-resistant disease.

Plain-language title generated from the registry record
Registry title: Clinical Study of PSMA-targeted CAR-T Cells in the Treatment of Castration-resistant Prostate Cancer

Key facts

Where
Xuzhou, ChinaSee the site
Phase
Phase 1

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Source: NCT05354375, who can take part

Where in China

  • Affiliated Hospital of Xuzhou Medical UniversityXuzhou, ChinaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
The Affiliated Hospital of Xuzhou Medical University
Trial code
NCT05354375
Record updated
29 April 2022
Original description
This is an experimental study to evaluate the safety and effectiveness of PSMA-targeted CAR-T cells in the treatment of castration-resistant prostate cancer.Read full original descriptionShow less

Clinical Study of PSMA-targeted CAR-T Cells in the Treatment of Castration-resistant Prostate Cancer

This is an experimental study to evaluate the safety and effectiveness of PSMA-targeted CAR-T cells in the treatment of castration-resistant prostate cancer.

Inclusion: Male patients aged from 18 to 75 years old; The patients' ECOG score ≤ 2; Prostate cancer patients in castration resistance stage (with or without distant metastasis):; Previous new endocrine therapy is ineffective; Past treatment with too much citabine or cabatase is ineffective; Have measurable or evaluable lesions; The patients' main tissues and organs function well:; Liver function: ALT/AST < 3 times the upper limit of normal value (ULN); renal function: creatinine < 220 μ mol/L; Lung function: indoor oxygen saturation ≥ 95%; Cardiac function: Left ventricular ejection fraction (LVEF)≥40%; Patients or their legal guardians voluntarily participate and sign the informed consent form.

Exclusion: Infectious diseases (such as HIV, active hepatitis B or C infection, active tuberculosis, etc.); Those with mental illness or mental illness who can't cooperate with treatment and curative effect evaluation; Highly allergic constitution or severe allergic history, especially those who are allergic to IL-2; Subjects with systemic infection or local severe infection who need anti-infection treatment; Complicated dysfunction of heart, lung, brain, liver, kidney and other important organs; Feasibility evaluation screening proves that the transfection of targeted lymphocytes is less than 10% or the amplification under the co-stimulation of CD3/CD28 is insufficient (< 5 times); The vital signs are abnormal and those who cannot cooperate with the inspectors; Patients with other tumors; Doctors think that there are other reasons that can't be included in the treatment.

ClinicalTrials.gov NCT05354375