Actively Recruiting
A Phase 1 Study of CG009301 for Injection in Adults With Relapsed or Refractory Blood Cancers Evaluating Safety, Dosing, and Preliminary Effects
Led by Cullgen (Shanghai),Inc · Updated on 2026-01-16
45
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and younger than 75 years at consent
- Diagnosed with relapsed or refractory haematological malignancies confirmed by pathology or cytology
- No available or tolerable standard treatments as judged by the investigator
- Specific diagnosis criteria for AML, high-risk MDS, or ALL as per WHO 2022 classification
- ECOG performance status score of 0 or 1
- Expected survival of at least 3 months as assessed by investigator
- Recovery from prior treatment toxicities to Grade 1 or less (except alopecia and stable chronic conditions)
- No recent autologous stem cell transplant or with resolved toxicities
- Adequate organ function based on laboratory tests and heart function assessments
- Non-pregnant, non-lactating with agreement to use effective contraception if applicable
- Able to understand study purpose and comply with study procedures and visits
You will not qualify if you...
- Central nervous system leukemia with neurological or psychiatric symptoms
- Recent anti-tumour therapy (within 4 weeks) or radiotherapy (within 2 weeks)
- Major surgery within 4 weeks prior or planned during the study
- Uncontrolled active infection despite treatment
- Severe or uncontrolled medical conditions such as respiratory, cardiovascular, endocrine, or psychiatric disorders
- Active autoimmune diseases or allergy to study drug
- Significant bleeding risk or recent major bleeding events
- Grade 2 or higher neuropathy excluding stable Grade 3
- Allogeneic stem cell transplant within 12 months
- Recent severe thromboembolic events or known thrombotic predisposition
- Positive tests for HIV, HBV, or HCV infections
- Recent live virus vaccination within 4 weeks
- History of alcohol or substance abuse
- Any other condition or abnormality that may interfere with study or safety as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 20 months
Participants receive CG009301 for Injection by intravenous infusion once daily for 7 consecutive days per 28-day cycle to treat relapsed or refractory blood cancers.
Daily visits during 7-day infusion per cycle; repeated cycles as determined by investigator
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
Q
Qiao Yi
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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