Actively Recruiting
A 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
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2026-01-02
186
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating QLS2309 injection in patients with CD70-positive relapsed or refractory blood cancers. This phase I clinical study is designed to assess how well patients tolerate the drug, its safety, how the body processes it, and its early effects against tumors. The study is open-label and takes place at multiple centers, focusing on patients whose disease has returned or not responded to previous treatments. The study involves administering QLS2309 through intravenous infusion once a week at doses starting at the maximum tolerated dose (MTD). The study includes several parts: dose escalation to find appropriate dosing levels and dose expansion to further evaluate safety and effectiveness. This single-arm trial does not include a placebo or comparison group. Participants will receive regular doses of QLS2309 and be closely monitored for side effects and drug levels in the body. Researchers will track dose-limiting toxicities over 28 days and continue to assess the recommended dose for up to 2 years. Patients will have assessments to evaluate their general health, organ function, and tumor response throughout their involvement, which may last for extended periods depending on treatment and monitoring needs.
CONDITIONS
Brief 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...
- Voluntary participation with signed informed consent
- Age 18 years or older, male or female
- ECOG performance status of 0 to 2
- Expected life expectancy of at least 3 months
- Diagnosis of CD70-positive relapsed or refractory hematologic malignancies
- Adequate organ function before receiving QLS2309
- Female participants with fertility agree to use effective contraception during the study and for 35 days after stopping the drug
- Male participants with partners of childbearing potential agree to use condoms during the study and for 35 days after stopping the drug
You will not qualify if you...
- Prior treatment with CD70-related antibodies, antibody-drug conjugates, or cell therapy products
- Symptomatic central nervous system involvement, leptomeningeal metastasis, or spinal cord compression from metastasis
- Active autoimmune diseases or history of grade 3 or higher immune-related adverse events from prior immunotherapy
- History of other active cancer within the past 3 years
- Received chemotherapy, biological therapy, endocrine therapy, immunotherapy, or monoclonal antibodies within 4 weeks prior to study
- Active infections such as hepatitis B or C, HIV, or syphilis (Treponema pallidum)
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 - Repeated 28-day cycles until disease progression or discontinuation.
Participants receive QLS2309 by intravenous infusion once weekly at the maximum tolerated dose.
Weekly visits for QLS2309 infusion
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
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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