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PD-1 Knockout Engineered T Cells for Muscle-invasive Bladder Cancer | Clinical Trials | Clareo Health

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

A Dose-escalation Phase I Trial of PD-1 Knockout Engineered T Cells for the Treatment of Muscle-invasive Bladder Cancer

NCT02863913•Peking University

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.

Detailed Description

This is a dose-escalation study of ex-vivo knocked-out, expanded, and selected PD-1 knockout-T cells from autologous origin. Patients are assigned to 1 of 3 treatment groups to determine the maximal tolerant dose. After the lower number of cycles are considered tolerant, an arm of the next higher number of cycles will be open to next patients. Biomarkers and immunological markers are collected and analyzed as well.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Department of Urology Peking University First Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

September 1, 2016

Primary Completion Date

September 1, 2019

Completion Date

September 1, 2019

Last Updated

March 6, 2019

Conditions

Invasive Bladder Cancer Stage IV

Interventions

PD-1 Knockout T Cells

BIOLOGICAL

Cyclophosphamide

DRUG

IL-2

DRUG