A Phase I Trial of QLS2313 Injection in Relapsed/Refractory Hematological Malignancies
NCT ID: NCT07294300
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
124 participants
INTERVENTIONAL
2026-01-31
2028-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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QLS2313
QLS2313
CD79b/CD3/CD20;first in human; subcutaneous injection
Interventions
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QLS2313
CD79b/CD3/CD20;first in human; subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Qilu Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Shanghai Jiaotong University School of Medicine Ruijin Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Other Identifiers
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QLS2313-101
Identifier Type: -
Identifier Source: org_study_id