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

Phase 1Not Yet RecruitingNCT06500507

Qilu Pharmaceutical Co., Ltd.90 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Relapsed or Refractory Multiple Myeloma

Interventions

QLS4131 InjectionDRUG

Participants confirming to the eligibility criteria will be assigned to 1 of the 9 dose groups (0.06/0.3/1 \~ 600 ug/kg, respectively) based on the sequence of inclusion.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

Outcomes

Primary Outcomes

Recommended Phase 2 Dose (RP2D)

Determination of the recommended phase 2 dose (RP2D) of QLS41315 injection in patient with relapsed or refractory multiple myeloma

Time frame: 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).

Time frame: Up to 2 years

Secondary Outcomes

Overall Response Rate (ORR)

ORR assessed by the IMWG response criteria

Time frame: Up to 2 years

Central Contacts

Gang An, MD, Ph.D

CONTACT

008613502181109 angang@ihcams.ac.cn

Data from ClinicalTrials.gov

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