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

Qilu Pharmaceutical

Status and phase

Enrolling

Phase 1

Conditions

Relapsed or Refractory Multiple Myeloma

Treatments

Drug: QLS32015

Study type

Interventional

Funder types

Industry

Identifiers

NCT05920876

QLS32015-101

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Known hypersensitivity to any of the ingredients of this product.
Diagnosis of active plasma cell leukemia or systemic light chain amyloidosis.
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.