Actively Recruiting
Phase 1 Study of TQB2029 Injection to Test Safety and Effects in Adults With Multiple Myeloma
Led by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Updated on 2024-12-06
136
Participants Needed
2
Research Sites
104 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating TQB2029 for injection in adults with multiple myeloma to determine the maximum tolerated dose, dose-limiting toxicities, adverse events, pharmacokinetics, pharmacodynamics, immunogenicity, and anti-tumor effects. The study includes a Phase Ia dose escalation period to assess safety and tolerability, followed by a Phase Ib dose extension period to evaluate treatment effectiveness. Participants receive TQB2029 injections in 28-day treatment cycles. The study monitors drug levels and immune response markers at multiple time points during the first and second treatment cycles. Immunogenicity is assessed at specified cycles and at the end of treatment. The trial aims to identify the recommended dose for future research. During the study, participants undergo regular evaluations including measurement of drug concentration, immune system activity, and treatment response. Researchers track adverse events and clinical outcomes such as remission rates and survival over up to 18 months. Safety and tolerability are closely monitored throughout the treatment period.
CONDITIONS
Brief Title
A Clinical Study of TQB2029 for Injection in Subjects With Multiple Myeloma
Research Team
T
Ting Niu, Doctor
P
Peng Liu, Doctor
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