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

Recruiting now · Phase 1

Conditions studied: Immunotherapy

In brief

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.

Key facts

Study ID

NCT05354375

Run by

The Affiliated Hospital of Xuzhou Medical University

People needed

20

Starts

2022-12-01

Expected to finish

2026-11-30

Last updated by the study team

2022-04-29

Who can join

Age: 18 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Infectious diseases (such as HIV, active hepatitis B or C infection, active tuberculosis, etc.);
• 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;
• 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;
• Patients with other tumors;
• Doctors think that there are other reasons that can't be included in the treatment.

Where it is running

• Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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