A Study of QLS4131 in Patients With Recurrent or Refractory Multiple Myeloma
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorQilu Pharmaceutical Co., Ltd.
About this trial
The purpose of this study is to characterize the safety of QLS4131 injection and to determine the recommended Phase 2 dose (RP2D) and to further evaluate the efficacy and safety of QLS4131 injection in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years old, regardless of gender.
Subjects should be willing and able to comply with the study schedule and protocols.
Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria.
Must have measurable disease as defined by the following: Serum M-protein greater than or equal to 1 g/dL; OR Urine M-protein greater than or equal to 200 mg/24 hours; OR Serum free light chain (FLC) assay; involved FLC level greater than or equal to 10 mg/dL provided the serum FLC ratio is abnormal.
Disqualifiers
Known hypersensitivity to any of the ingredients of this product.
Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
Has any active severe mental illness, medical illness, or other symptoms/conditions that may affect treatment, compliance, or the ability to provide informed consent, as determined by the investigator.
Trial design
Design model
Single group
Treatments tested in this trial
QLS4131 Injection
DrugParticipants confirming to the eligibility criteria will be assigned to 1 of the 9 dose groups (0.06/0.3/1 \~ 600 ug/kg, respectively) based on the sequence of inclusion.
Treatment groups
90 Participants
are divided into 1 treatment groupGroup A: QLS4131Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recommended Phase 2 Dose (RP2D)
Determination of the recommended phase 2 dose (RP2D) of QLS41315 injection in patient with relapsed or refractory multiple myeloma
Time frame
Approximately 2 years2
Incidence of adverse events（AEs）
Assessing the incidence of adverse events (AEs) using the Common Terminology Criteria for Adverse Events (CTCAE Version 5).
Time frame
Up to 2 yearsSecondary outcomes
1
Overall Response Rate (ORR)
ORR assessed by the IMWG response criteria
Time frame
Up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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