Back to resultsA Study of QLS32015 in Patients With Recurrent or Refractory Multiple Myeloma
Primary Purpose
Relapsed or Refractory Multiple Myeloma
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
QLS32015
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed or Refractory Multiple Myeloma
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.
Sites / Locations
- Institute of Hematology & Blood Diseases HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
QLS32015
Arm Description
Dose escalation and does expansion of QLS32015 injection will be evaluated.
Outcomes
Primary Outcome Measures
Recommended Phase 2 Dose (RP2D)
Determination of the recommended phase 2 dose (RP2D) of QLS32015 injection in patient with relapsed or refractory multiple myeloma.
Incidence of adverse events（AEs）
Assessing the incidence of adverse events (AEs) using the Common Terminology Criteria for Adverse Events (CTCAE Version 5).
Secondary Outcome Measures
Overall Response Rate (ORR)
ORR assessed by the IMWG response criteria.
Full Information
NCT ID
NCT05920876
First Posted
June 15, 2023
Last Updated
June 24, 2023
Sponsor
Qilu Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05920876
Brief Title
A Study of QLS32015 in Patients With Recurrent or Refractory Multiple Myeloma
Official Title
Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Effectiveness of QLS32015 Injection in Patients With Relapsed or Refractory Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
QLS32015
Arm Type
Experimental
Arm Description
Dose escalation and does expansion of QLS32015 injection will be evaluated.
Intervention Type
Drug
Intervention Name(s)
QLS32015
Other Intervention Name(s)
A Humanized GPRC5D x CD3 Bispecific Antibody
Intervention Description
Participants will receive subcutaneous (SC) injection of QLS32015. Eight dose groups were proposed, 21 days as a treatment cycle.
Primary Outcome Measure Information:
Title
Recommended Phase 2 Dose (RP2D)
Description
Determination of the recommended phase 2 dose (RP2D) of QLS32015 injection in patient with relapsed or refractory multiple myeloma.
Time Frame
Approximately 2 years
Title
Incidence of adverse events（AEs）
Description
Assessing the incidence of adverse events (AEs) using the Common Terminology Criteria for Adverse Events (CTCAE Version 5).
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
ORR assessed by the IMWG response criteria.
Time Frame
Up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gang An
Phone
008613502181109
Email
angang@ihcams.ac.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lugui Qiu
Organizational Affiliation
Chinese Academy of Medical Sciences & Peking Union Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Hematology & Blood Diseases Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lugui Qiu
Phone
86-022-23909282
Email
qiulg@ihcams.ac.cn
12. IPD Sharing Statement
Learn more about this trial
A Study of QLS32015 in Patients With Recurrent or Refractory Multiple Myeloma
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