Actively Recruiting
Phase 1 Study Evaluating Safety and Effectiveness of SHR-3079 Injection in Adults with B-cell Non-Hodgkin Lymphoma
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2026-08-07
90
Participants Needed
2
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating SHR-3079, a drug being studied for safety, tolerability, and preliminary effectiveness in adults with B-cell non-Hodgkin lymphoma who have received prior treatments without success or have progressive disease. This phase 1 study aims to identify dose-limiting toxicity, maximum tolerated dose, and recommended dose for future studies. Participants receive SHR-3079 injection in a single group without placebo comparison. The study monitors dose-limiting toxicity during the first 28 days after treatment starts, with longer follow-up of about one year to determine the maximum tolerated dose and recommended phase 2 dose. The treatment period includes careful monitoring of adverse events and drug pharmacokinetics. During the study, participants undergo assessments to measure drug safety, side effects, and how the drug behaves in the body. Researchers evaluate response rates, duration and timing of response, progression-free survival, and overall survival over approximately one year. Participants must comply with contraceptive requirements and attend follow-up visits for safety and efficacy evaluations, with study participation lasting up to two years including monitoring.
CONDITIONS
Brief Title
A Clinical Study of SHR-3079 in B-cell Non-Hodgkin Lymphoma
Research Team
W
Wei Ji, M.M
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