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

Summary

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.

Eligibility

Inclusion Criteria:

1. Male patients aged from 18 to 75 years old;
2. The patients' ECOG score ≤ 2;
3. Prostate cancer patients in castration resistance stage (with or without distant metastasis):

   1. Previous new endocrine therapy is ineffective;
   2. Past treatment with too much citabine or cabatase is ineffective.
4. Have measurable or evaluable lesions;
5. The patients' main tissues and organs function well:

   1. Liver function: ALT/AST \< 3 times the upper limit of normal value (ULN);
   2. renal function: creatinine \< 220 μ mol/L;
   3. Lung function: indoor oxygen saturation ≥ 95%;
   4. Cardiac function: Left ventricular ejection fraction (LVEF)≥40%
6. Patients or their legal guardians voluntarily participate and sign the informed consent form.

Exclusion Criteria:

1. Infectious diseases (such as HIV, active hepatitis B or C infection, active tuberculosis, etc.);
2. 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);
3. The vital signs are abnormal and those who cannot cooperate with the inspectors;
4. Those with mental illness or mental illness who can't cooperate with treatment and curative effect evaluation;
5. Highly allergic constitution or severe allergic history, especially those who are allergic to IL-2;
6. Subjects with systemic infection or local severe infection who need anti-infection treatment;
7. Complicated dysfunction of heart, lung, brain, liver, kidney and other important organs;
8. Patients with other tumors;
9. Doctors think that there are other reasons that can't be included in the treatment.

Conditions2

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