Actively Recruiting
A Phase 1 Study of CG009301 for Injection in Adult Subjects With Recurrent or Refractory Haematological Malignancies
Led by Cullgen (Shanghai),Inc · Updated on 2026-01-16
45
Participants Needed
3
Research Sites
141 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 1 Study of CG009301 for Injection in Adult Subjects With Recurrent or Refractory Haematological Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and under 75 years at consent
- Diagnosis of relapsed or refractory haematological malignancies confirmed by pathology or cytology
- For dose-expansion phase, diagnosis of AML, high-risk MDS, or ALL according to WHO 2022 criteria
- ECOG performance status score of 0-1
- Expected survival of at least 3 months as assessed by investigator
- Recovery from prior treatment toxicities to Grade 1 or less (excluding alopecia and stable chronic conditions)
- No prior autologous stem cell transplant, or transplant done more than 2 months ago with toxicity recovery to Grade 1 or less
- Adequate organ function including coagulation, liver, kidney, heart function, and QTc interval within specified limits
- Non-pregnant and non-lactating, with agreement to use effective contraception if of childbearing potential
- Ability to understand and voluntarily sign informed consent and comply with study procedures
You will not qualify if you...
- Central nervous system leukemia with neurological or psychiatric symptoms
- Antitumour therapy (except hydroxyurea or prophylactic intrathecal injections) within 4 weeks prior to first dose
- Radiotherapy or traditional Chinese medicine within 2 weeks prior to first dose
- Major surgery within 4 weeks before first dose or planned during study
- Uncontrolled active infections after treatment
- Severe or uncontrolled respiratory, cardiovascular, endocrine, neurological, or psychiatric conditions
- Active autoimmune diseases or allergy to study drug or ingredients
- Significant bleeding risk or recent major bleeding events
- Grade 2 or higher neuropathy (except stable Grade 3 lasting over 6 months without impairment)
- Allogeneic stem cell transplant within 12 months prior to first dose
- Recent serious thromboembolic events or known high thrombotic risk
- Positive tests for HIV, active HBV or HCV infection
- Live virus vaccination within 4 weeks before first dose
- History of alcohol or substance abuse
- Any medical or laboratory condition interfering with study participation or results
AI-Screening
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Trial Site Locations
Total: 3 locations
1
The First Affiliated Hospital of Nanchang University
Nanchang, China
Actively Recruiting
2
The Haematology Hospital of the Chinese Academy of Medical Sciences
Tianjin, China
Actively Recruiting
3
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Actively Recruiting
Research Team
X
Xiangyu Jin, MS
CONTACT
Q
Qiao Yi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
10
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