A Study of QLS32015 in Patients With Recurrent or Refractory Multiple Myeloma
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: QLS32015 Dose escalation and does expansion of QLS32015 injection will be evaluated. |
Drug: QLS32015
Participants will receive subcutaneous (SC) injection of QLS32015. Eight dose groups were proposed, 21 days as a treatment cycle.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Recommended Phase 2 Dose (RP2D) [Approximately 2 years]
Determination of the recommended phase 2 dose (RP2D) of QLS32015 injection in patient with relapsed or refractory multiple myeloma.
- Incidence of adverse events（AEs） [Up to 2 years]
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) [Up to 2 years]
ORR assessed by the IMWG response criteria.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥18 years old, regardless of gender.
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Subjects should be willing and able to comply with the study schedule and protocols.
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Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria.
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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:
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Known hypersensitivity to any of the ingredients of this product.
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Diagnosis of active plasma cell leukemia or systemic light chain amyloidosis.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institute of Hematology & Blood Diseases Hospital | Tianjin | Tianjin | China | 300020 |
Sponsors and Collaborators
- Qilu Pharmaceutical Co., Ltd.
Investigators
- Principal Investigator: Lugui Qiu, Chinese Academy of Medical Sciences & Peking Union Medical College
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- QLS32015-101