Spots Global Cancer Trial Database for A Study of QLS32015 in Patients With Recurrent or Refractory Multiple Myeloma

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Trial Identification

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

Official Title: Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Effectiveness of QLS32015 Injection in Patients With Relapsed or Refractory Multiple Myeloma

Study ID: NCT05920876

Conditions

Relapsed or Refractory Multiple Myeloma

Interventions

QLS32015

Study Description

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.