Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of Toripalimab for Patients With Recurrent Malignant Lymphoma
Study of a Study Medicine for Recurrent Malignant Lymphoma
Brief description of study
The primary objective is to assess the safety and tolerability of JS-001 in subjects with recurrent malignant lymphoma, and to evaluate its preliminary efficacy.
The secondary objectives are to: 1) characterize the single-dose and multi-dose pharmacokinetic (PK) profile of JS-001, 2) characterize the immunogenicity of JS-001; 3) assess the dose-efficacy relationship of JS-001 single agent, and 4) preliminarily evaluate biomarkers associated with the efficacy of JS-001.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Lymphoma
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Age: 25 years - 100 years
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Gender: Male
The purpose of this research study is to learn about the safety and tolerability (how well people can handle side effects) of a study medicine in people with recurrent malignant lymphoma (lymphoma that has come back). The study will also look at the study medicine’s early effects on the lymphoma.
Participants will receive the study medicine. The study will also measure how the medicine moves through the body after 1 dose and after multiple doses (pharmacokinetics). It will check whether the body makes an immune response against the medicine (immunogenicity). The study will also look at how the dose relates to the medicine’s effects and will explore biological markers (biomarkers) that may be linked to how the medicine works.
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