NCT07347171

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

A Phase 1, Open-label, Multicentre Study Evaluating the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics, and Preliminary Efficacy of CG009301 for Injection in Adult Subjects With Relapsed or Refractory Haematological Malignancies

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Cullgen (Shanghai),Inc · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will employ a multicentre, open-label design to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic characteristics, and preliminary efficacy of CG009301 for injection in adult subjects with relapsed or refractory haematological malignancies. This Phase I trial will comprise two phases, corresponding to the following indications: Dose-escalation study - Relapsed/refractory haematological malignancies, regardless of tumour type; Dose-expansion phase: Relapsed/refractory (R/R) acute myeloid leukaemia (AML), high-risk myelodysplastic syndromes (HR-MDS), and R/R acute lymphoblastic leukaemia (ALL).

Conditions

• Leukemia
• AML
• MDS
• AML (Acute Myelogenous Leukemia)
• MDS (Myelodysplastic Syndrome)

Interventions

Type	Name	Description
DRUG	CG009301 for Injection	0.9% Sodium Chloride Injection diluted to 250mL，Cycle 1 and subsequent cycles, IV, infusion duration: 2 hours, once daily (QD) administration for 7 days continuously(28 days constituting one cycle)

Timeline

• Start date: 2025-04-17
• Primary completion: 2027-12-30
• Completion: 2027-12-30
• First posted: 2026-01-16
• Last updated: 2026-01-16

Locations

3 sites across 1 country: China