Status:
SUSPENDED
LIGHT-PSMA-CART in Treating Patients With Castrate-Resistant Prostate Cancer
Lead Sponsor:
Bioray Laboratories
Collaborating Sponsors:
Changhai Hospital
Conditions:
Castrate-Resistant Prostate Cancer
Eligibility:
MALE
18-75 years
Phase:
PHASE1
Brief Summary
This is a single center, single arm Phase I study to establish the safety and efficacy of intravenously administered lentivirally transduced LIGHT-PSMA-specific CAR modified autologous T cells (PSMA-C...
Detailed Description
This is a Phase I study evaluating the safety and efficacy of PSMA targeting autologous CAR T cells co-expressing LIGHT in a 3+3 dose escalation design. Cohort 1 subjects (N=3 or 6) will receive a tol...
Eligibility Criteria
Inclusion
- Fully understand and voluntarily sign informed consent.
- Male, aged 18 to 75 years old.
- Expected survival \> 6 months.
- CRPC patients: Prostate cancer is still progressing after continuous androgen deprivation therapy. Including, castrate levels of serum testosterone (\<50ng/dl or \<1.7nmol/L); or prostate specific antigen (PSA) increased more than 50% at intervals of one week or three consecutive times, and PSA\>1 ug/L; or imaging scans revealed two or more new lesions or enlargement of soft tissue lesions that met the criteria for evaluating solid tumor response.
- CRPC patients received abiraterone or chemotherapy for 3 months or more, and were ineffective or progressive (PSA continued to rise for 3 months, or bone scan/whole-body MRI/PET-CT showed local recurrence or new metastasis).
- Immunohistochemical staining of repetitive biopsy tissues showed the expression of PSMA in tumor cells was more than 50%.
- ECOG score \<2.
- Hgb \> 10 g/dl.
- PLT \> 100×109/L.
- ANC \> 1.5×109/L.
Exclusion
- Subjects who meet any of the following exclusion criteria will be excluded
- Prior treatment with any immunotherapy, including CART therapy, tumor vaccine therapy, radium-223, checkpoint inhibitors.
- Prior treatment with any PSMA targeting therapy.
- Subjects with severe mental disorders.
- Subjects with severe cardiovascular diseases: a, New York Heart Association (NYHA) stage III or IV congestive heart failure; b, history of myocardial infarction or coronary artery bypass grafting (CABG) within 6 months; c, clinical significance of ventricular arrhythmia, or history of unexplained syncope, non-vasovagal or dehydration; d, history of severe non-ischemic cardiomyopathy; e, the left ventricular ejection fraction (LVEF \< 55%) was decreased by echocardiography or MUGA scan (within 8 weeks before PBMC collection), and abnormal interventricular septal thickness and atrioventricular size associated with myocardial amyloidosis.
- Patients with ongoing or active infection.
- Aspartate aminotransferase or Alanine aminotransferase \>2.5\*ULN; CK\>1.5\*ULN; CK-MB\>1.5\*ULN; TnT\>1.5\*ULN.
- Total bilirubin \>1.5\*ULN.
- Partial prothrombin time or activated partial thromboplastin time or international standardized ratio \> 1.5\*ULN without anticoagulant treatment.
- History of participation in other clinical studies within 3 months or treatment with any gene therapy product.
- Intolerant or allergic to cyclophosphamide or fludarabine.
- Subjects not appropriate to participate in this clinical study judged by investigators.
Key Trial Info
Start Date :
July 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 15 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04053062
Start Date
July 16 2020
End Date
October 15 2024
Last Update
January 5 2024
Active Locations (1)
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1
Changhai Hospital
Shanghai, Shanghai Municipality, China, 200433