Actively Recruiting
Safety and Efficacy Study of An Anti-CD38 Antibody Drug Conjugate in Relapsed or Refractory Multiple Myeloma
Led by Zhejiang ACEA Pharmaceutical Co. Ltd. · Updated on 2025-08-15
84
Participants Needed
4
Research Sites
262 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase Ib/IIa, open-label, dose-escalation, and extension study to evaluate the safety and efficacy of an anti-CD38 antibody drug conjugate (STI-6129) in patients with relapsed or refractory multiple myeloma.
CONDITIONS
Official Title
Safety and Efficacy Study of An Anti-CD38 Antibody Drug Conjugate in Relapsed or Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Previously treated with at least three drugs including proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody, and relapsed or refractory after the most recent multiple myeloma therapy
- Diagnosed with multiple myeloma according to IMWG criteria with measurable lesions defined by at least one of: serum M protein ≥ 0.5 g/dL, urine M protein ≥ 200 mg/24 hours, or affected serum free light chain level ≥ 10 mg/dL when ratio is abnormal
- ECOG performance status score of 0, 1, or 2
- Willing and able to follow study schedule and protocol requirements
- Women of childbearing potential must have a negative pregnancy test at screening and female participants and male participants with fertility potential must use highly effective contraception from screening to 6 months after last treatment
You will not qualify if you...
- Known allergy to any ingredients of the study drug
- Active plasma cell leukemia diagnosis
- Diagnosis of systemic light chain amyloidosis
- Multiple myeloma involving the central nervous system
- POEMS syndrome diagnosis
- Spinal cord compression related to multiple myeloma
- Use of drugs strongly affecting CYP3A4 enzyme
- Plasma exchange therapy within 28 days before first study drug administration
- Recent anti-tumor treatments within specified time frames before first study drug dose
- CAR-T therapy or allogeneic stem cell transplant within 6 months before first dose or active graft-versus-host disease at screening
- Autologous stem cell transplant within 12 weeks before first dose
- Major surgery or eye surgery within 28 days before first dose
- Other cancers within 3 years before first dose
- Severe ocular diseases or neuropathy of grade 3 or higher
- Unresolved toxicity from previous anti-tumor treatment above grade 1
- Low hemoglobin, platelet, or neutrophil counts before first dose
- Poor kidney function or abnormal liver tests before first dose
- Severe or uncontrolled heart and brain blood vessel diseases
- Chronic lung diseases or uncontrolled asthma or interstitial lung disease requiring treatment
- Active infections or need for IV antibiotics within 72 hours before first dose
- Active or uncontrolled hepatitis B, hepatitis C, or HIV infection
- Currently pregnant or breastfeeding
- Severe mental illness or other conditions affecting treatment or consent according to investigator assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Beijing Chao-Yang Hospital，Capital Medicine University
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
2
Peking university Third hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
3
The first affiliated hospital ,Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Actively Recruiting
4
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
C
chao wang, master
CONTACT
M
meiping kong, bachelor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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