A Phase I Trial of QLS2313 Injection in Relapsed/Refractory Hematological Malignancies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QLS2313.
- Who it may be relevant to
- Registry conditions: Relapsed/Refractory Hematological Malignancies. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- Drug QLS2313
CD79b/CD3/CD20;first in human; subcutaneous injection
Primary outcome measures
- DLT, MTD, RPIbD, and RP2D [Time frame: to 2 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Jiaotong University School of Medicine Ruijin Hospital — Shanghai
Identifiers
NCT: NCT07294300 · QLS2313-101