Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLS32015 | Experimental | Dose escalation and does expansion of QLS32015 injection will be evaluated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLS32015 | Drug | Participants will receive subcutaneous (SC) injection of QLS32015. Eight dose groups were proposed, 21 days as a treatment cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recommended Phase 2 Dose (RP2D) | Determination of the recommended phase 2 dose (RP2D) of QLS32015 injection in patient with relapsed or refractory multiple myeloma. | Approximately 2 years |
| Incidence of adverse events(AEs) | Assessing the incidence of adverse events (AEs) using the Common Terminology Criteria for Adverse Events (CTCAE Version 5). | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR assessed by the IMWG response criteria. | Up to 2 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gang An | Contact | 008613502181109 | angang@ihcams.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Lugui Qiu | Chinese Academy of Medical Sciences & Peking Union Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital | Recruiting | Tianjin | Tianjin Municipality | 300020 | China |
Not provided
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |