QLS2313: CD79b/CD3/CD20;first in human; subcutaneous injection
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Males or females aged ≥ 18 years;
2. 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;
3. Having a measurable disease defined by appropriate disease response criteria;
4. Subjects with sufficient organ function prior to the first dose of the investigational drug
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0 or 1
Exclusion Criteria:
1. Previous treatment with a CD79b/CD3/CD20 trispecific antibody;
2. Known central nervous system (CNS) involvement;
3. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation/bone marrow transplantation;
4. Treatment with autologous stem cell transplantation within 3 months;
5. Prior genetically modified adoptive cell therapy (e.g., chimeric antigen receptor T cells \[CAR-T\] and natural killer cells \[CAR-NK\]) within 3 months
6. Presence of viral, bacterial or uncontrolled fungal infection requiring intravenous drug infusion within 1 week prior to the first dose
7. 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.
Primary outcome measure(s)
DLT, MTD, RPIbD, and RP2D — 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.
Trial sites (1)
Facility
City
Region
Status
Shanghai Jiaotong University School of Medicine Ruijin Hospital
Shanghai
Shanghai Municipality
More Qilu Pharmaceutical Co., Ltd. trials in China
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.
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