Actively Recruiting
Phase I Clinical Study: BG1805 Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
Led by Guangzhou Bio-gene Technology Co., Ltd · Updated on 2025-04-17
24
Participants Needed
3
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-arm, single-dose dose-escalation and dose-expansion study.
CONDITIONS
Official Title
Phase I Clinical Study: BG1805 Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign informed consent and commit to follow-up examinations and treatments
- Aged between 18 and 70 years inclusive
- Diagnosed with acute myeloid leukemia (AML) as per 2016 WHO classification
- Meet diagnostic criteria for relapsed or refractory AML according to Chinese guidelines
- AML blast cells test positive for CLL-1 expression at 50% or higher by flow cytometry
- Recovered from prior treatment toxicities to grade less than 2 unless tumor-related or stable
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 with predicted survival over 3 months
- Adequate organ function including liver enzymes, bilirubin, kidney function, hemoglobin, oxygen saturation, and heart ejection fraction
- Female participants must be infertile or have a negative pregnancy test and agree to contraception during and one year after study
- Male participants of childbearing potential must agree to contraception or abstinence until one year after last dose
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia
- Other malignancies within 3 years except certain treated cancers
- Central nervous system involvement or cranial neuropathy
- Positive for hepatitis B, hepatitis C, HIV, cytomegalovirus, Epstein-Barr virus, or syphilis antibodies
- History of severe allergic reactions or allergy to study drugs or related products
- Severe cardiac disease including serious arrhythmias, unstable angina, or heart failure
- Previous organ transplant or preparing for transplant (except stem cell transplant)
- Acute or chronic graft-versus-host disease
- Hematopoietic stem-cell transplant within 6 months before screening
- Active autoimmune, inflammatory, or serious cerebrovascular diseases
- Cancer emergencies needing urgent treatment before screening
- Uncontrolled infections needing antibiotics
- Recent major surgery within 4 weeks or unhealed surgical wounds
- Severe mental illness
- Recent use of certain blood growth factors or immunosuppressive drugs before cell collection
- Live vaccine within 4 weeks before screening
- History of alcohol or substance abuse
- Participation in other clinical trials within 3 months
- Previous CAR-T or other cell therapy
- Any condition judged to pose unacceptable risk by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
ZhuJiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510280
Actively Recruiting
2
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510515
Actively Recruiting
3
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
M
Min Luo, Doctorate
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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