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Chimeric Antigen Receptor T Cells (CART) Therapy in prostatic cancer (CaP)

Chimeric Antigen Receptor T Cells (CART) Therapy in prostatic cancer (CaP)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027577
Enrollment
Unknown
Registered
2019-11-19
Start date
2019-11-28
Completion date
Unknown
Last updated
2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostatic cancer (CaP)

Interventions

Sponsors

The Fifth Hospital Affiliated to Zhongshan University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18-80 years. 2. PAP expression> 1 + as determined by immunohistochemistry (IHC) in a laboratory accredited by the sponsor; 3. Pathology confirmed prostatic cancer (CaP); 4. Unable to operate or not suitable for surgery patients. 5. According to RECIST 1.1 version of the standard has at least one measles extracranial lesions. 6. Expected survival >= 60 days. 7. The main organs function properly. 8. Hemorrhagic disease or coagulation disorders. 9. Allergy to developer. 10. Participants voluntarily joined the study, signed informed consent, good compliance with follow-up.

Exclusion criteria

Exclusion criteria: 1. T cell transduction efficiency 140 mmHg, diastolic> 90 mmHg), patients with grade I or higher myocardial ischemia or myocardial infarction, grade I and above arrhythmias Including QT interval >= 440ms) or complete cardiac function; 6. Long-term unhealed chest or other parts of the wound or fracture; 7. Those with history of abuse of psychotropic substances who can not be abstinent or who have mental disorders; 8. Past and current patients with objective evidence of a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-associated pneumonia, severely impaired pulmonary function; 9. There are fungi, bacteria, viruses or other infections that can not be controlled or require antimicrobial treatment. If there is a response to active therapy, a simple urinary tract infection and no complication of bacterial pharyngitis are allowed after consultation with the medical examiner; 10. For subjects with previously used chemotherapy, >= 2 hematologic toxicity or >= 3 non-hematologic toxicity at enrollment according to NCI-CTCAE 4.0 criteria; 11. A known history of HIV or Hepatitis B (HBsAg positive) or Hepatitis C virus (anti-HCV positive) infection is known; 12. There are any indwelling catheters or drains (eg, percutaneous nephrostomy tubes, indwelling Foley catheters, bile ducts, or pleural / peritoneal / pericardial catheters). Allow use of a dedicated central venous catheter; 13. brain metastases; 14. There is a CNS history or disease, such as seizure disease, cerebrovascular ischemia / hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving CNS; 15. There is a significant immunodeficiency; 16. Have a history of severe hypersensitivity reactions to the major therapeutic agents used in this study, including fludarabine, cyclophosphamide, mesna, and tocilizumab and anti-infectives against CRS during pretreatment; 17. There was a history of deep venous thrombosis or pulmonary embolism within the first 6 months of enrollment.

Design outcomes

Primary

MeasureTime frame
PET CT;

Countries

China

Contacts

Public ContactJunjie Mao
linmin@sidansai.com+86 15618108082

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026