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Trial Title:
A Study of QLS4131 in Patients With Recurrent or Refractory Multiple Myeloma
NCT ID:
NCT06500507
Condition:
Relapsed or Refractory Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
QLS4131 Injection
Description:
Participants 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.
Arm group label:
QLS4131
Other name:
A novel tri-specific humanized antibody
Summary:
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.
Detailed description:
Multiple myeloma (MM) is a malignant disease with abnormal proliferation of clonal plasma
cell, which is often accompanied by multiple osteolytic damage, hypercalcemia, anemia,
and kidney damage. QLS4131 is a novel tri-specific humanized antibody. The study consists
3 periods: screening phase, treatment phase and a post-treatment follow-up phase. The
study will evaluate safety, tolerability, pharmacokinetics and preliminary antitumor
activity of QLS4131 administered to participants with relapsed or refractory multiple
myeloma. Total duration of study is up to 2 years.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥18 years old, regardless of gender.
2. Subjects should be willing and able to comply with the study schedule and protocols.
3. Documented initial diagnosis of multiple myeloma according to International Myeloma
Working Group (IMWG) diagnostic criteria.
4. 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.
Exclusion Criteria:
1. Known hypersensitivity to any of the ingredients of this product.
2. Known active central nervous system (CNS) involvement or exhibits clinical signs of
meningeal involvement of multiple myeloma.
3. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institute of Hematology & Blood Diseases Hospital
Address:
City:
Tianjin
Zip:
300020
Country:
China
Contact:
Last name:
Gang An, MD
Phone:
008613502181109
Email:
angang@ihcams.ac.cn
Start date:
August 30, 2024
Completion date:
January 31, 2027
Lead sponsor:
Agency:
Qilu Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Qilu Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06500507
