An Open-Label, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SHR-3079 Injection in Participants With B-Cell Non-Hodgkin Lymphoma
The study is being conducted to evaluate the safety and tolerability of SHR-3079, and to explore the Dose-limiting Toxicity (DLT), Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D). This study also preliminarily evaluated the efficacy of SHR-3079 in patients with B-cell non-Hodgkin lymphoma.
• Aged ≥ 18 years old;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1, expected survival ≥ 3 months;
• Histologically confirmed B-NHL;
• Participant population: Have received ≥ 1 line of standard anti-tumor treatment, and have not achieved response after the latest treatment or have progressive disease after the treatment;
• Have measurable lesions;
• Have adequate organ function;
• Male participants and female participants of childbearing potential must use adequate and effective contraceptive measures during the study and within 3 months after the last drug administration of SHR-3079. Female participants must not be lactating and must have a negative blood HCG test result within 7 days before the first dose;
• Voluntarily sign the ICF, have good compliance, and be willing to cooperate with follow-up.