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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Relapsed or Refractory Multiple Myeloma
• Intervention / Treatment: Drug: QLS32015

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Gang An; Phone Number: 008613502181109; Email: angang@ihcams.ac.cn

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300020
      • Recruiting
      • Institute of Hematology & Blood Diseases Hospital
      • Contact: Lugui Qiu; Phone Number: 86-022-23909282; Email: qiulg@ihcams.ac.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QLS32015; Dose escalation and does expansion of QLS32015 injection will be evaluated.	Drug: QLS32015; Participants will receive subcutaneous (SC) injection of QLS32015. Eight dose groups were proposed, 21 days as a treatment cycle.; Other Names: A Humanized GPRC5D x CD3 Bispecific Antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events（AEs）	Assessing the incidence of adverse events (AEs) using the Common Terminology Criteria for Adverse Events (CTCAE Version 5).	Up to 2 years
Recommended Phase 2 Dose (RP2D)	Determination of the recommended phase 2 dose (RP2D) of QLS32015 injection in patient with relapsed or refractory multiple myeloma.	Approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR)	ORR assessed by the IMWG response criteria.	Up to 2 years

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Lugui Qiu, Chinese Academy of Medical Sciences & Peking Union Medical College

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: June 15, 2023
• First Submitted That Met QC Criteria: June 24, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 24, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Physiological Effects of Drugs; Immunologic Factors; Antibodies, Bispecific
• Other Study ID Numbers: QLS32015-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No