Status:
RECRUITING
Clinical Study of PSMA-targeted CAR-T Cells in the Treatment of Castration-resistant Prostate Cancer
Lead Sponsor:
The Affiliated Hospital of Xuzhou Medical University
Collaborating Sponsors:
Xuzhou Medical University
Conditions:
Immunotherapy
Eligibility:
MALE
18-75 years
Phase:
PHASE1
Brief 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.
Detailed Description
We designed a clinical study and divided the trial into two phases. Phase 1 (climbing test): 9 patients were randomly divided into 3 groups (n=3). 9 patients were treated with cyclophosphamide at the...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- 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;
- Patients with other tumors;
- Doctors think that there are other reasons that can't be included in the treatment.
Key Trial Info
Start Date :
December 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05354375
Start Date
December 1 2022
End Date
November 30 2026
Last Update
April 29 2022
Active Locations (1)
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1
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221000