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

NCT ID: NCT06500507

Last Updated: 2024-07-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-30
• Study Completion Date: 2027-01-31

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.

Conditions

Relapsed or Refractory Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

QLS4131

Dose escalation and does expansion of QLS4131 injection will be evaluated.

Group Type: EXPERIMENTAL

QLS4131 Injection

Intervention Type: DRUG

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.

Interventions

QLS4131 Injection

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.

Intervention Type: DRUG

Other Intervention Names

A novel tri-specific humanized antibody

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gang An, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences

Locations

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

Countries

China

Central Contacts

Gang An, MD, Ph.D

Role: CONTACT

angang@ihcams.ac.cn

008613502181109

Facility Contacts

Gang An, MD

Role: primary

angang@ihcams.ac.cn

008613502181109

Other Identifiers

QLS4131-101

Identifier Type: -

Identifier Source: org_study_id