An open-label, multi-center, non-randomized phase I dose escalation study to investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ONO-4685 given as monotherapy in patients with relapsed or refractory T-cell Lymphoma
Sponsor: |
Ono therapeutics |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAU5779 |
U.S. Govt. ID: |
NCT05079282 |
Contact: |
Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu |
The purpose of this study is to find out the safety, effectiveness, and blood levels of various doses of the study drug in participants with T-cell lymphoma that has not improved or has gotten worse. ONO-4685 is an experimental drug which is not approved by Health Authorities including the United States Food and Drug Administration (FDA). The study drug is a protein made in laboratory called an antibody. Antibodies are made naturally in our body and are a key part of our immune system. The study drug antibody targets 2 specific proteins: a protein called PD-1 on cancer cells and protein called CD3 on immune cells. The goal of the study drug is to improve your immune system's ability to fight the cancer cells.
Investigator
Barbara Pro, MD
Are you at least 18 years old? |
Yes |
No |
Have you been diagnosed with T-cell lymphoma? |
Yes |
No |
Have you had at least 2 previous types of treatment? |
Yes |
No |
Are you willing to come to the clinic for additional evaluations and treatments? |
Yes |
No |