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Clinical Trials in China / NCT07173595
Recruiting Phase 1

A Phase I Study of QLS2309 Injection in Patients With CD70+ Relapsed/Refractory Hematologic Malignancies

NCT07173595 · tracked via the Priya Life Science China tracker
Sponsor
Qilu Pharmaceutical Co., Ltd.
Phase
Phase 1
Started
2025-12-05
Last updated
2026-01-02

Condition(s) studied

Relapsed or Refractory Hematologic Malignancies

Investigational drug(s) / intervention(s)

QLS2309

QLS2309: initial dose - MTD; QW; intravenous infusion

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 1\. Subjects voluntarily participated and signed a written informed consent form * 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: * Prior treatment with CD70-related antibodies, antibody-conjugated drugs (ADCs) or cell therapy products * 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking University People's Hospital Beijing Beijing Municipality Recruiting

More Qilu Pharmaceutical Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07173595 on ClinicalTrials.gov ↗ ← All trials in China