Using CAR-T cells to treat advanced prostate cancer

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

This study is testing a new type of immune cell treatment for advanced prostate cancer to see if it can help patients whose cancer isn't responding to standard treatments.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Male
• Sponsor: The Affiliated Hospital of Xuzhou Medical University (other)
• Drugs / interventions: CAR-T, CAR T, chemotherapy, cyclophosphamide
• Locations: 1 site (Xuzhou, Jiangsu)
• Trial ID: NCT05354375 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are male patients aged 18 to 75 with castration-resistant prostate cancer who have not responded to previous treatments.

Not a fit: Patients with active infectious diseases or those whose health conditions do not meet the study's eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new, effective option for patients with advanced prostate cancer that is resistant to standard therapies.

How similar studies have performed: Other studies using CAR-T cell therapy for various cancers have shown promising results, suggesting potential success for this approach in prostate cancer as well.

Eligibility criteria

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 this trial is running

Xuzhou, Jiangsu

• 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

Conditions: Immunotherapy, Prostate specific membrane antigen, Castration-resistant Prostate Cancer, CAR-T, Chimeric antigen receptor, T cell