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NCT05354375RecruitingPhase 1

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

Source: ClinicalTrials.gov · Last updated 29 Apr 2022 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
20 (estimated)
First submitted
26 Apr 2022
Start date
Dec 2022
Primary completion date
Nov 2025
Lead sponsor
The Affiliated Hospital of Xuzhou Medical University
NCT number
NCT05354375

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 20
  • From Dec 2022 to the primary completion date, Nov 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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;

Lab values

  • 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);

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Affiliated Hospital of Xuzhou Medical University
Coordinator of this site? Confirm its status
XuzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.