Clinical Study of Safety and Efficacy of Enhanced PSMA CAR- T in Refractory CRPC (NCT06228404) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Clinical Study of Safety and Efficacy of Enhanced PSMA CAR- T in Refractory CRPC
China18 participantsStarted 2024-03-03
Plain-language summary
This is one center, single-arm, open-label investigator initiated trial to assess the safety and efficacy of enhanced autologous PSMA chimeric antigen receptor T cells in the treatment for patients with refractory castration resistant prostate cancer, and the sample size is set to 7-18 subjects.
Who can participate
Age range18 Years – 75 Years
SexMALE
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Inclusion criteria
✓. Fully understood and voluntarily signed informed consent for this study;
✓. Receiving CRPC standard treatment (such as new endocrine therapy, chemotherapy and radium-223, etc., one or more of the combination therapy) after the diagnosis of CRPC, ineffective or progressive disease (PSA continued to rise for 3 months, or bone scan/whole-body MRI/PET-CT showed local recurrence or new metastatic lesions, demonstrating disease progression);
✓. PSMA expression in tumor cells was positive in immunohistochemical staining of prostate/metastatic biopsy tissue before enrollment;
✓. ECOG score \< 2 ;
✓. virological examination HAV (hepatitis A virus), HBV (hepatitis B virus), HCV (hepatitis C virus), HIV (human immunodeficiency virus), TP (Treponema pallidum) quantitative detection was negative, (antigen and antibody screening method unknown, confirmed by nucleic acid method); hematological parameters met the following criteria: a. hemoglobin \> 100 g/L; b. platelet count \> 100 × 109/L; c. neutrophils \> 1.5 × 109/L.
Exclusion criteria
✕. have received any previous treatment with CAR-T therapy ;
✕. have received any previous treatment that targets PSMA;
What they're measuring
1
DLT
Timeframe: Within 28 Days After Enhanced autologous PSMA-CAR T Infusion
2
The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE V5.0)
Timeframe: Through 6 months after CAR-T cell infusion
3
Cytokine Release Syndrome (CRS) grading post CAR T cell infusion
Timeframe: Through 6 months after CAR-T cell infusion
. tumor pathology suggests a special type of prostate cancer (e.g., neuroendocrine prostate cancer, etc.)
✕. severe mental disorders;
✕. suffered from previous malignancies, except for the following: a. basal cell carcinoma or squamous cell carcinoma after standardized treatment; b. having a primary malignancy, but completely resected, with a complete remission time of ≥ 5 years.
✕. Subjects with severe cardiovascular disease; a.New York Heart Association (NYHA) stage III or IV congestive heart failure; b.Myocardial infarction ≤ 6 months prior to enrollment or coronary artery bypass graft (CABG); c.Clinically significant ventricular arrhythmia, or history of unexplained syncope, nonvasovagal or not due to dehydration; d.History of severe non-ischemic cardiomyopathy; e.Decreased left ventricular ejection fraction (LVEF \< 55%) as assessed by echocardiogram or multigated acquisition (MUGA) scan, abnormal interventricular septal thickness and atrioventricular size associated with myocardial amyloidosis;
✕. active infectious disease or any major infectious event requiring high grade antibiotics;
✕. organ function in the following abnormalities: a. serum aspartate aminotransferase or alanine aminotransferase \> 2.5ULN; CK \> ULN; CK-MB \> ULN; TnT \> 1.5ULN; b. total bilirubin \> 1.5ULN; c. partial prothrombin time or activated partial thromboplastin time or international normalized ratio \> 1.5ULN in the absence of anticoagulant therapy;