Relapsed/Refractory Hematological Malignancies
Conditions
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.
Interventions
DRUGQLS2313
CD79b/CD3/CD20;first in human; subcutaneous injection
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactWeili Zhao, PhD
Outcome results
None listed