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Trial Title:
A Study of QLS32015 in Patients With Recurrent or Refractory Multiple Myeloma
NCT ID:
NCT05920876
Condition:
Relapsed or Refractory Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Antibodies, Bispecific
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
QLS32015
Description:
Participants will receive subcutaneous (SC) injection of QLS32015. Eight dose groups were
proposed, 21 days as a treatment cycle.
Arm group label:
QLS32015
Other name:
A Humanized GPRC5D x CD3 Bispecific Antibody
Summary:
The purpose of this study is to characterize the safety of QLS32015 injection and to
determine the recommended Phase 2 dose (RP2D) and to further evaluate the efficacy and
safety of QLS32015 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. QLS32015 is a humanized immunoglobulin gamma-1 (IgG1) type bispecific
antibody targeting G protein-coupled receptor family C group 5-member D (GPRC5D) and
cluster of differentiation 3 (CD3). 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 QLS32015
administered to participants with relapsed or refractory multiple myeloma. Total duration
of study is up to 2 years.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Known hypersensitivity to any of the ingredients of this product.
- Diagnosis of active plasma cell leukemia or systemic light chain amyloidosis.
- 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
Status:
Recruiting
Contact:
Last name:
Lugui Qiu
Phone:
86-022-23909282
Email:
qiulg@ihcams.ac.cn
Start date:
June 30, 2023
Completion date:
August 31, 2025
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/NCT05920876
