Actively Recruiting
A Phase I Study of QLS2309 Injection in Patients With CD70+ Relapsed/Refractory Hematologic Malignancies
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2026-01-02
186
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-arm, open-label, multicenter, dose-escalation, dose-expansion and efficacy-expansion phase I clinical study to evaluate the tolerability, safety, pharmacokinetics and preliminary antitumor activity of QLS2309 injection in patients with CD70+ relapsed/refractory hematologic malignancies.
CONDITIONS
Official Title
A Phase I Study of QLS2309 Injection in Patients With CD70+ Relapsed/Refractory Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects voluntarily participated and signed a written informed consent form
- Age 18 years or older, male or female
- ECOG performance status of 0-2
- Expected life expectancy of at least 3 months
- Diagnosed with CD70-positive relapsed or refractory hematologic malignancies
- Adequate organ function before receiving QLS2309
- Female patients with fertility must agree to use effective contraception during the study and for 35 days after stopping the drug
- Male patients with female partners of childbearing age must agree to use condoms during the study and for 35 days after stopping the drug
You will not qualify if you...
- Previous treatment with CD70-related antibodies, antibody-conjugated drugs, or cell therapy products
- Symptomatic central nervous system involvement, leptomeningeal metastasis, or spinal cord compression caused by metastasis
- Active autoimmune diseases or history of grade 3 or higher immune-related adverse events from prior immunotherapy
- History of other active malignant tumors within the past 3 years
- Received chemotherapy, biological therapy, endocrine therapy, immunotherapy, or monoclonal antibodies within the past 4 weeks
- Known active hepatitis B or C infection, HIV infection, or Treponema pallidum infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100032
Actively Recruiting
Research Team
X
Xiaojun Huang, MD
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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