Clinical Trial

A Phase 1 Study of CG009301 for Injection in Adult Subjects With Recurrent or Refractory Haematological Malignancies

Recruiting Phase 1
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Summary
The goal of this clinical trial is to learn about the safety of drug CG009301. It also learns if drug CG009301 works to treat in Participants with relapsed or refractory adult haematological malignancies. The main question\[s\] it aims to answer are: 1. To determine the maximum tolerated dose (MTD) and/or objective best dose (OBD) of CG009301 for injection in subjects with relapsed or refractory adult haematological malignancies. 2. To establish subsequent dosing regimens for CG009301 for injection. 3. To characterise the safety profile and tolerability of CG009301 for injection. Participants will Receive treatment with CG009301 until disease progression.
Trial Details
NCT Number NCT07347171
Lead Sponsor Cullgen (Shanghai),Inc
Conditions Leukemia, AML, MDS, AML (Acute Myelogenous Leukemia), MDS (Myelodysplastic Syndrome)
Enrollment 45 participants
Start Date 2025-04-17
Primary Completion 2027-12-30 (estimated)
Study Completion 2027-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-16