About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Male patients aged from 18 to 75 years old;
The patients' ECOG score ≤ 2;
Previous new endocrine therapy is ineffective;
Past treatment with too much citabine or cabatase is ineffective.
Disqualifiers
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;
Trial design
Single group
Treatments tested in this trial
CAR-T cell immunotherapy
Biological/VaccineThis CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at PSMA.
Treatment groups
Trial outcomes
Primary outcomes
Safety Evaluation:Incidence and Severity of Adverse Events
To evaluate the incidence and severity of possible adverse events within one month after targeted PSMA CAR-T infusion, including cytokine release syndrome and on-target toxicity.
Effectiveness Evaluation
In order to observe the efficacy of CAR-T cells after infusion, total remission rate (ORR), complete remission (CR), partial remission (PR), disease stability (SD) or progression (PD) will be used for evaluation.
Secondary outcomes
Progression-free Survival (PFS)
Progression-free survival (PFS) time
Overall Survival (OS)
Overall survival (OS) time
Sponsors and contacts
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The Affiliated Hospital of Xuzhou Medical University
Lead sponsor
Xuzhou Medical University
Collaborator