A Phase I Study of QLS2309 Injection in Patients With CD70+ Relapsed/Refractory Hematologic Malignancies
NCT ID: NCT07173595
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
186 participants
INTERVENTIONAL
2025-12-05
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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QLS2309
QLS2309
initial dose - MTD; QW; intravenous infusion
Interventions
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QLS2309
initial dose - MTD; QW; intravenous infusion
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years, male or female
* ECOG performance status of 0-2
* Expected life-expectancy ≥ 3 months
* CD70+ relapsed/refractory hematologic malignancies
* Adequate organ function prior to QLS2309 administration
* Female patients with fertility must agree to the use of effective contraceptive methods during the study period and within 35 days of discontinuation of the trial drug.
* Male patients whose sexual partners are women of childbearing age must agree to use condoms during the study period and within 35 days of discontinuation of the trial drug during sexual intercourse.
Exclusion Criteria
* Symptomatic central nervous system (CNS) involvement, leptomeningeal metastasis or spinal cord compression caused by metastasis
* An active autoimmune diseases or known history of ≥ grade 3 irAE due to prior immunotherapy
* Known history of other active malignant tumor within 3 years
* Known history of chemotherapy, biological therapy, endocrine therapy, immunotherapy, monoclonal antibodies, etc. within 4 weeks
* Known history of active hepatitis B/C infection, HIV infection, Treponema pallidum infection
18 Years
ALL
No
Sponsors
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Qilu Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Peking University People's Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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QLS2309-101
Identifier Type: -
Identifier Source: org_study_id
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