Search / Trial NCT06228404

Clinical Study of Safety and Efficacy of Enhanced PSMA CAR- T in Refractory CRPC

Launched by SHANGHAI CHANGZHENG HOSPITAL · Jan 19, 2024

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Trial Information

Current as of October 09, 2024

Recruiting

Keywords

Castration Resistant Prostate Cancer Metastasis Prostate Specific Membrane Antigen Chimeric Antigen Receptor T Cell Refractory Castration Resistant Prostate Cancer

Description

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. Based on the "3 + 3" dose escalation design principle, subjects will be divided into 3 groups from low dose to high dose in sequence (Group A; Group B; Group C). Additional subjects will be enrolled into the RP2D group to ensure that 6-9 efficacy-evaluable subjects are available in the RP2D group be...

Gender

MALE

Eligibility criteria

  • Inclusion Criteria:
  • 1. Fully understood and voluntarily signed informed consent for this study;
  • 2. male, aged 18-75 years;
  • 3. expected survival of more than 6 months;
  • 4. metastatic castration-resistant prostate adenocarcinoma (CRPC) patients.
  • 5. 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);
  • 6. PSMA expression in tumor cells was positive in immunohistochemical staining of prostate/metastatic biopsy tissue before enrollment;
  • 7. ECOG score \< 2 ;
  • 8. 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:
  • Subjects meeting any of the following exclusion criteria will be excluded:
  • 1. have received any previous treatment with CAR-T therapy ;
  • 2. have received any previous treatment that targets PSMA;
  • 3. tumor pathology suggests a special type of prostate cancer (e.g., neuroendocrine prostate cancer, etc.)
  • 4. severe mental disorders;
  • 5. 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.
  • 6. 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;
  • 7. active infectious disease or any major infectious event requiring high grade antibiotics;
  • 8. 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;
  • 9. participation in other clinical studies in the past three months or previous treatment with any gene therapy product;
  • 10. intolerance or hypersensitivity to cyclophosphamide and fludarabine chemotherapy;
  • 11. unsuitability to participate in this clinical study in the opinion of the investigator.

About Shanghai Changzheng Hospital

Shanghai Changzheng Hospital, affiliated with the Second Military Medical University, is a leading medical institution in China known for its comprehensive clinical services and advanced research capabilities. With a commitment to improving patient outcomes and advancing medical knowledge, the hospital actively engages in clinical trials across various therapeutic areas. Its multidisciplinary team of healthcare professionals collaborates with researchers and industry partners to facilitate innovative studies, ensuring adherence to the highest ethical and regulatory standards. By leveraging its state-of-the-art facilities and expertise, Shanghai Changzheng Hospital aims to contribute significantly to the development of new treatments and therapies that enhance patient care.

Locations

Shanghai, Shanghai, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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