A Phase I Trial of QLS2313 Injection in Relapsed/Refractory Hematological Malignancies

NCT07294300 | Not Yet Recruiting Phase 1

• 1 other identifier: QLS2313-101
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Relapsed/Refractory Hematological Malignancies

Outcome Measures

Primary Outcomes (1)

• DLT, MTD, RPIbD, and RP2D

  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.

  to 2 years

Study Arms (1)

QLS2313

EXPERIMENTAL

Drug: QLS2313

Interventions

QLS2313 DRUG

CD79b/CD3/CD20;first in human; subcutaneous injection

QLS2313

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai Jiaotong University School of Medicine Ruijin Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Weili Zhao, PhD

CONTACT

15214370575; zwl_trial@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 19, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

CN (1)