Actively Recruiting

Phase 1
Age: 18Years - 75Years
MALE
NCT05354375

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

Led by The Affiliated Hospital of Xuzhou Medical University · Updated on 2022-04-29

20

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

Sponsors

T

The Affiliated Hospital of Xuzhou Medical University

Lead Sponsor

X

Xuzhou Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male patients aged from 18 to 75 years old
  • ECOG performance score of 2 or less
  • Diagnosed with castration-resistant prostate cancer, with or without distant metastasis
  • Previous new endocrine therapy was ineffective
  • Previous treatment with citabine or cabazitaxel was ineffective
  • Presence of measurable or evaluable lesions
  • Good liver function with ALT/AST less than 3 times the upper limit of normal
  • Kidney function with creatinine less than 220 micromol/L
  • Lung function with oxygen saturation of at least 95%
  • Heart function with left ventricular ejection fraction of 40% or more
  • Willingness to participate and sign informed consent
Not Eligible

You will not qualify if you...

  • Infectious diseases such as HIV, active hepatitis B or C, or active tuberculosis
  • Insufficient lymphocyte transfection or amplification under CD3/CD28 co-stimulation
  • Abnormal vital signs or inability to cooperate with study procedures
  • Mental illness preventing cooperation with treatment and evaluation
  • Severe allergies or allergic history, especially to IL-2
  • Systemic or severe local infections requiring treatment
  • Severe dysfunction of heart, lung, brain, liver, kidney, or other major organs
  • Presence of other tumors
  • Any other reasons deemed by doctors to exclude participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China, 221000

Actively Recruiting

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Research Team

H

Hailong Li, M.D/Ph.D

CONTACT

Q

Qing Zhang, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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