RecruitingPhase 1NCT07347171

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


Sponsor

Cullgen (Shanghai),Inc

Enrollment

45 participants

Start Date

Apr 17, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase study testing a new investigational drug called CG009301 in people with blood cancers — specifically acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or acute lymphoblastic leukemia (ALL) — that has come back or stopped responding to standard treatments. **You may be eligible if...** - You are 18–74 years old - You have a confirmed diagnosis of relapsed or refractory AML, MDS, or ALL, and no standard treatment options remain - Your general health (ECOG score) is 0 or 1 - Your expected survival is at least 3 months - Your organs are functioning at acceptable levels **You may NOT be eligible if...** - You have leukemia in the brain with neurological or psychiatric symptoms - You have had chemotherapy, immunotherapy, or targeted therapy in the past 4 weeks (or 5 half-lives) - You have a serious uncontrolled infection, heart condition, or other severe medical illness - You have active autoimmune disease - You have HIV, active hepatitis B, or hepatitis C - You have had an allogeneic stem cell transplant in the past 12 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCG009301 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)


Locations(3)

The First Affiliated Hospital of Nanchang University

Nanchang, China

The Haematology Hospital of the Chinese Academy of Medical Sciences

Tianjin, China

Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

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NCT07347171


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