A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of QLS2313 for Injection in Patients With Relapsed/Refractory Hematological Malignancies

Qilu Pharmaceutical Co., Ltd.1 site in 1 country124 target enrollmentJanuary 1, 2026

InterventionsQLS2313

Overview

Phase: Phase 1
Intervention: QLS2313
Conditions: Not specified
Sponsor: Qilu Pharmaceutical Co., Ltd.
Enrollment: 124
Locations: 1
Primary Endpoint: DLT, MTD, RPIbD, and RP2D
Status: Not yet recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is an open-label, dose-escalation and efficacy-expansion Phase I clinical trial to evaluate the safety, tolerability, PK profile, immunogenicity, and preliminary antitumor activity of QLS2313 as a monotherapy in patients with relapsed/refractory hematological malignancies.

Registry

clinicaltrials.gov

Start Date

January 1, 2026

End Date

February 1, 2028

Last Updated

4 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Qilu Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males or females aged ≥ 18 years；
•Patients with relapsed/refractory hematological malignancies, specifically patients with B-cell NHL or CLL/small lymphocytic lymphoma (SLL) as defined by the 2022 World Health Organization (WHO) classification, who are relapsed/refractory and have no standard of care available as judged by the investigator;
•Having a measurable disease defined by appropriate disease response criteria;
•Subjects with sufficient organ function prior to the first dose of the investigational drug
•Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0 or 1

Exclusion Criteria

•Previous treatment with a CD79b/CD3/CD20 trispecific antibody；
•Known central nervous system (CNS) involvement；
•Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation/bone marrow transplantation；
•Treatment with autologous stem cell transplantation within 3 months;
•Prior genetically modified adoptive cell therapy (e.g., chimeric antigen receptor T cells \[CAR-T\] and natural killer cells \[CAR-NK\]) within 3 months
•Presence of viral, bacterial or uncontrolled fungal infection requiring intravenous drug infusion within 1 week prior to the first dose
•Presence of chronic or acute active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, defined as HBV-5 test at screening indicating active infection (positive HBsAg and/or positive HBcAb) with HBV-DNA \> ULN, or positive HCVAb and positive HCV-RNA, allowed for antiviral therapy.

Arms & Interventions

QLS2313

Intervention: QLS2313

Outcomes

Primary Outcomes

DLT, MTD, RPIbD, and RP2D

Time Frame: to 2 years

To evaluate the tolerability and safety of subcutaneously administered QLS2313 for Injection in patients with hematological malignancies, and to determine the MTD, RPIbD, and RP2D.