Phase II Study of QLS32015 Combination Therapy in the Treatment of Multiple Myeloma

NCT ID: NCT07018050

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-12
• Study Completion Date: 2028-07-31

Brief Summary

The purpose of the study is to compare the efficacy of QLS32105 (SC) in combination with Pomalidomide, and QLS32105 (SC) in combination with QL2109 or Daratumumab, and QLS32105 (SC) in combination with QL2109 or Daratumumab and Pomalidomide, and QLS32105(SC) in combination with Bortezomib and Lenalidomide.

Conditions

Relapsed or Refractory Multiple Myeloma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

QLS32015(SC) in combination with Pomalidomide

Participants will receive QLS32015 as SC injections; Pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.

Group Type: EXPERIMENTAL

QLS32015

Intervention Type: DRUG

QLS32015 will be administered subcutaneously

Pomalidomide

Intervention Type: DRUG

Pomalidomide will be self-administered as a single dose orally

Dexamethasone

Intervention Type: DRUG

Dexamethasone will be administered orally or intravenously

QLS32015(SC) in combination with QL2109 or Daratumumab.

Participants will receive QLS32015 and QL2109 or Daratumumab as SC injections; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.

Group Type: EXPERIMENTAL

QLS32015

Intervention Type: DRUG

QLS32015 will be administered subcutaneously

Dexamethasone

Intervention Type: DRUG

Dexamethasone will be administered orally or intravenously

QL2109 or Daratumumab

Intervention Type: DRUG

QL2109 or Daratumumab will be administered subcutaneously.

QLS32015(SC) in combination with QL2109 or Daratumumab and Pomalidomide

Participants will receive QLS32015 and QL2109 or Daratumumab as SC injections; Pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug

Group Type: EXPERIMENTAL

QLS32015

Intervention Type: DRUG

QLS32015 will be administered subcutaneously

Pomalidomide

Intervention Type: DRUG

Pomalidomide will be self-administered as a single dose orally

Dexamethasone

Intervention Type: DRUG

Dexamethasone will be administered orally or intravenously

QL2109 or Daratumumab

Intervention Type: DRUG

QL2109 or Daratumumab will be administered subcutaneously.

QLS32015(SC) in combination with Bortezomib for injection and Lenalidomide

Participants will receive QLS32015 and Bortezomib as SC injections; Lenalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug

Group Type: EXPERIMENTAL

QLS32015

Intervention Type: DRUG

QLS32015 will be administered subcutaneously

Dexamethasone

Intervention Type: DRUG

Dexamethasone will be administered orally or intravenously

Bortezomib

Intervention Type: DRUG

Bortezomib will be administered subcutaneously

Lenalidomide

Intervention Type: DRUG

Lenalidomide will be self-administered as a single dose orally

Interventions

QLS32015

QLS32015 will be administered subcutaneously

Intervention Type: DRUG

Pomalidomide

Pomalidomide will be self-administered as a single dose orally

Intervention Type: DRUG

Dexamethasone

Dexamethasone will be administered orally or intravenously

Intervention Type: DRUG

QL2109 or Daratumumab

QL2109 or Daratumumab will be administered subcutaneously.

Intervention Type: DRUG

Bortezomib

Bortezomib will be administered subcutaneously

Intervention Type: DRUG

Lenalidomide

Lenalidomide will be self-administered as a single dose orally

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnosis of multiple myeloma confirmed according to the 2016 International Myeloma Working Group (IMWG) diagnostic criteria;
• Prior therapy: Relapsed, progressed, or intolerant to ≥1 prior line of anti-multiple myeloma therapy;
• Measurable disease at screening, defined by at least one of the following:

• Serum M-protein ≥1.0 g/dL (10 g/L);
• Urine M-protein ≥200 mg/24 hours;
• Serum immunoglobulin free light chain ≥10 mg/dL (100 mg/L) with an abnormal serum immunoglobulin κ/λ free light chain ratio.

Exclusion Criteria

• History of Grade 3 or higher cytokine release syndrome (CRS) associated with any T-cell redirecting therapy (e.g., CD3-redirecting technologies or CAR-T cell therapy);
• Prior anti-myeloma therapies within the specified timeframes before enrollment:

• Previous treatment with GPRC5D-targeted therapy;
• Genetically modified adoptive cell therapy (e.g., chimeric antigen receptor T-cell [CAR-T], natural killer [NK] cell therapy) within 3 months;
• Targeted therapy, investigational drugs, or invasive investigational medical devices within 21 days or 5 half-lives (whichever is longer);
• Monoclonal antibodies or bispecific antibody therapy for multiple myeloma within 21 days or 5 half-lives (whichever is longer);
• Cytotoxic therapy within 21 days;
• Proteasome inhibitor therapy within 14 days;
• Immunomodulatory drug therapy within 7 days;
• Radiotherapy within 14 days (except low-dose palliative radiation [10-30 Gy]);
• Prior intolerance to Pomalidomide (applies to treatment cohorts containing Pomalidomide);
• Prior intolerance to Bortezomib (applies to treatment cohorts containing bortezomid);
• Prior intolerance to Lenalidomide (applies to treatment cohorts containing Lenalidomide);
• Prior intolerance to Daratumumab (applies to treatment cohorts containing Daratumumab).

• 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

Locations

Institute of Hematology & Blood Diseases Hospital

Tianjin, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Gang An, Professor

Role: CONTACT

angang@ihcams.ac.cn

008613502181109

Facility Contacts

Gang An

Role: primary

angang@ihcams.ac.cn

008613502181109

Other Identifiers

QLS32015-202

Identifier Type: -

Identifier Source: org_study_id