RecruitingPhase 1NCT07173595

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

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

Sponsor

Qilu Pharmaceutical Co., Ltd.

Enrollment

186 participants

Start Date

Dec 5, 2025

Study Type

INTERVENTIONAL

Conditions

Relapsed or Refractory Hematologic Malignancies

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

Min Age: 18 Years

Inclusion Criteria8

\. 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 Criteria6

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