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
Study of ONO-4685 in Patients with 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
Additional Study Information: 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
Do You Qualify?
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
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For more information, please contact:
Research Nurse Navigator
cancerclinicaltrials@cumc.columbia.edu
212-342-5162