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

ConditionImmunotherapy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-75
SponsorThe Affiliated Hospital of Xuzhou Medical University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • CAR-T cell immunotherapy

    Biological/Vaccine

    This CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at PSMA.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: CAR-T cell immunotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
First 1 month after CAR-T cells infusion
2

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.

Time frame
3 months after CAR-T cells infusion

Secondary outcomes

1

Progression-free Survival (PFS)

Progression-free survival (PFS) time

Time frame
24 months after CAR-T cells infusion
2

Overall Survival (OS)

Overall survival (OS) time

Time frame
24 months after CAR-T cells infusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.