NCT06500507

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

Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Effectiveness of QLS4131 Injection in Patients With Relapsed or Refractory Multiple Myeloma

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2024-08-30
• Primary completion: 2026-03-31
• Completion: 2027-01-31
• First posted: 2024-07-15
• Last updated: 2024-07-15

Locations

1 site across 1 country: China