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)
Safety Evaluation:Incidence and Severity of Adverse Events — First 1 month after CAR-T cells infusion 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 — 3 months after CAR-T cells infusion 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.
Trial sites (1)
Facility
City
Region
Status
Affiliated Hospital of Xuzhou Medical University
Xuzhou
Jiangsu
Recruiting
More The Affiliated Hospital of Xuzhou Medical University trials in China
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.
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