A Study of QLS4131 in Patients With Recurrent or Refractory Multiple Myeloma

Phase 1

Not yet recruiting

• Conditions: Relapsed or Refractory Multiple Myeloma
• Interventions: Drug: QLS4131 Injection

• Registration Number: NCT06500507
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

Brief Summary

The purpose of this study is to characterize the safety of QLS4131 injection and to determine the recommended Phase 2 dose (RP2D) and to further evaluate the efficacy and safety of QLS4131 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. QLS4131 is a novel tri-specific humanized antibody. 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 QLS4131 administered to participants with relapsed or refractory multiple myeloma. Total duration of study is up to 2 years.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-08
• Last Update Submitted: 2024-07-08
• Study First Posted: 2024-07-15
• Last Update Posted: 2024-07-15
• Study Start: 2024-08-30
• Primary Completion: 2026-03-31
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Age ≥18 years old, regardless of gender.
2. Subjects should be willing and able to comply with the study schedule and protocols.
3. Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria.
4. 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

1. Known hypersensitivity to any of the ingredients of this product.
2. Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
3. 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
QLS4131	QLS4131 Injection	Dose escalation and does expansion of QLS4131 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 QLS41315 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