PD-1 Knockout Engineered T Cells for Muscle-invasive Bladder Cancer

• Status: Withdrawn
• Trial end date: 2019-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety of PD-1 knockout engineered T cells in treating metastatic advanced bladder cancer. Blood samples will also be collected for research purposes.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University
• Collaborator: Cell Biotech Co., Ltd.
• Treatments: Cyclophosphamide; Interleukin-2; Polystyrene sulfonic acid

Criteria

Inclusion Criteria:

• Pathologically verified stage IV muscle-invasive bladder cancer with measurable lesions (On CT: longest diameter of tumoral lesion >=10 mm, shorted diameter of lymph node >=15 mm; measurable lesions should not have been irradiated)

• Progressed after all standard treatment

• Performance score: 0-1

• Expected life span: >= 6 months

• Toxicities from prior treatment has resolved. Washout period is 4 weeks for chemotherapy, and 2 weeks for targeted therapy

• Major organs function normally

• Women at pregnant ages should be under contraception

• Willing and able to provide informed consent

Exclusion Criteria:

• Pathology is mixed type

• Emergent treatment of tumor emergency is needed

• Poor vasculature

• Coagulopathy, or ongoing thrombolytics and/or anticoagulation

• Blood-borne infectious disease, e.g. hepatitis B

• History of mandatory custody because of psychosis or other psychological disease inappropriate for treatment deemed by treating physician

• With other immune diseases, or chronic use of immunosuppressants or steroids

• Compliance cannot be expected

• Other conditions requiring exclusion deemed by physician