Using CAR-T cells to treat advanced prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study evaluates the safety and effectiveness of PSMA-targeted CAR-T cells in patients with castration-resistant prostate cancer. The trial is divided into two phases: Phase 1 focuses on determining the maximum tolerated dose of CAR-T cells, while Phase 2 administers the optimal dose to additional patients. Participants will receive pre-treatment chemotherapy followed by CAR-T cell infusion and regular monitoring of their health and cancer markers. The study aims to assess the therapeutic potential of this innovative immunotherapy approach.

Why it matters

Who can join: the full rules

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.

Where it's running

• Affiliated Hospital of Xuzhou Medical University
  Xuzhou, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Hailong Li, M.D/Ph.D — The Affiliated Hospital of Xuzhou Medical University
• Study coordinator: Hailong Li, M.D/Ph.D
• Email: Justinlee719@163.com
• Phone: 0086-17798835021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.