A Phase I Trial of QLS2313 Injection in Relapsed/Refractory Hematological Malignancies
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorQilu Pharmaceutical Co., Ltd.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
QLS2313
DrugCD79b/CD3/CD20;first in human; subcutaneous injection
Treatment groups
124 Participants
are divided into 1 treatment groupGroup A: QLS2313Experimental treatment 1 intervention
Trial outcomes
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.
Time frame
to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: