Actively Recruiting
Phase 1 Study of CG009301 Injection for Adults with Relapsed or Refractory Blood Cancers Evaluating Safety, Dosage, and Effectiveness in Leukemia and Related Disorders
Led by Cullgen (Shanghai),Inc · Updated on 2026-01-16
45
Participants Needed
3
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying the safety, tolerability, and preliminary effects of CG009301 for injection in adults with relapsed or refractory blood cancers, including acute myeloid leukemia AML, high-risk myelodysplastic syndromes HR-MDS, and acute lymphoblastic leukemia ALL. This Phase 1, open-label trial aims to find the best dose and dosing schedule for CG009301 and to better understand its safety profile in participants who have limited treatment options. Participants will receive CG009301 through an intravenous infusion diluted in sodium chloride daily for 7 days per 28-day cycle. The study has two phases a dose-escalation phase for various relapsed or refractory blood cancers, followed by a dose-expansion phase focusing on AML, HR-MDS, and ALL. Treatment continues until the disease progresses. During the trial, participants will undergo regular assessments including safety monitoring, laboratory tests, and evaluations of drug levels in the body. Researchers will measure outcomes such as the recommended dose for expansion, duration of treatment cycles, adverse events, and clinical responses over periods up to 20 months or longer. Participants are expected to comply with scheduled visits and tests throughout the study duration.
CONDITIONS
Brief Title
A Phase 1 Study of CG009301 for Injection in Adult Subjects With Recurrent or Refractory Haematological Malignancies
Research Team
X
Xiangyu Jin, MS
Q
Qiao Yi
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