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Clinical Trials in China / NCT05354375
Recruiting Phase 1

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

NCT05354375 · tracked via the Priya Life Science China tracker
Sponsor
The Affiliated Hospital of Xuzhou Medical University
Phase
Phase 1
Started
2022-12-01
Last updated
2022-04-29

Condition(s) studied

Immunotherapy

Investigational drug(s) / intervention(s)

CAR-T cell immunotherapy

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

Study summary

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

Sex
MALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu Recruiting

More The Affiliated Hospital of Xuzhou Medical University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05354375 on ClinicalTrials.gov ↗ ← All trials in China