A Study of QLS32015 in Patients With Recurrent or Refractory Multiple Myeloma

Phase 1

Recruiting

• Conditions: Relapsed or Refractory Multiple Myeloma
• Interventions: Drug: QLS32015

• Registration Number: NCT05920876
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

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.

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-15
• Study First Submitted QC: 2023-06-24
• Last Update Submitted: 2023-06-24
• Study First Posted: 2023-06-27
• Last Update Posted: 2023-06-27
• Study Start: 2023-06-30
• Primary Completion: 2024-12-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
QLS32015	QLS32015	Dose escalation and does expansion of QLS32015 injection will be evaluated.

Primary Outcome Measures

Name	Time	Method
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).
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.

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	Up to 2 years	ORR assessed by the IMWG response criteria.

Trial Locations

Locations (1)

Institute of Hematology & Blood Diseases Hospital; 🇨🇳 Tianjin, Tianjin, China