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

NCT ID: NCT05920876

Last Updated: 2023-06-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2025-08-31

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.

Conditions

Relapsed or Refractory Multiple Myeloma

Study Design

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

Study Groups

QLS32015

Dose escalation and does expansion of QLS32015 injection will be evaluated.

Group Type: EXPERIMENTAL

QLS32015

Intervention Type: DRUG

Participants will receive subcutaneous (SC) injection of QLS32015. Eight dose groups were proposed, 21 days as a treatment cycle.

Interventions

QLS32015

Participants will receive subcutaneous (SC) injection of QLS32015. Eight dose groups were proposed, 21 days as a treatment cycle.

Intervention Type: DRUG

Other Intervention Names

A Humanized GPRC5D x CD3 Bispecific Antibody

Eligibility Criteria

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.

• 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

Lugui Qiu

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences & Peking Union Medical College

Locations

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Gang An

Role: CONTACT

angang@ihcams.ac.cn

008613502181109

Facility Contacts

Lugui Qiu

Role: primary

qiulg@ihcams.ac.cn

86-022-23909282

Other Identifiers

QLS32015-101

Identifier Type: -

Identifier Source: org_study_id