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

NCT07018050 | Recruiting Phase 2

• 1 other identifier: QLS32015-202
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• ORR (Partial Response [PR] or Better)

  Overall response (PR or better) is defined as percentage of participants who have a PR or better per International Myeloma Working Group (IMWG) criteria

  Up to 2 years

• Overall Minimal Residual Disease (MRD)

  MRD-negative is defined as proportion of participants who achieve MRD negativity at a threshold of 10\^-5 at any timepoint after the first dose of study drug and before disease progression or start of subsequent antimyeloma therapy

  Up to 2 years

Secondary Outcomes (1)

• Progression-Free Survival (PFS)

  Up to 2 years

Study Arms (4)

QLS32015(SC) in combination with Pomalidomide

EXPERIMENTAL

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.

Drug: QLS32015; Drug: Pomalidomide; Drug: Dexamethasone

QLS32015(SC) in combination with QL2109 or Daratumumab.

EXPERIMENTAL

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.

Drug: QLS32015; Drug: Dexamethasone; Drug: QL2109 or Daratumumab

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

EXPERIMENTAL

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

Drug: QLS32015; Drug: Pomalidomide; Drug: Dexamethasone; Drug: QL2109 or Daratumumab

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

EXPERIMENTAL

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

Drug: QLS32015; Drug: Dexamethasone; Drug: Bortezomib; Drug: Lenalidomide

Interventions

QLS32015 DRUG

QLS32015 will be administered subcutaneously

QLS32015(SC) in combination with Bortezomib for injection and Lenalidomide; QLS32015(SC) in combination with Pomalidomide; QLS32015(SC) in combination with QL2109 or Daratumumab and Pomalidomide; QLS32015(SC) in combination with QL2109 or Daratumumab.

Pomalidomide DRUG

Pomalidomide will be self-administered as a single dose orally

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

Dexamethasone DRUG

Dexamethasone will be administered orally or intravenously

QLS32015(SC) in combination with Bortezomib for injection and Lenalidomide; QLS32015(SC) in combination with Pomalidomide; QLS32015(SC) in combination with QL2109 or Daratumumab and Pomalidomide; QLS32015(SC) in combination with QL2109 or Daratumumab.

QL2109 or Daratumumab DRUG

QL2109 or Daratumumab will be administered subcutaneously.

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

Bortezomib DRUG

Bortezomib will be administered subcutaneously

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

Lenalidomide DRUG

Lenalidomide will be self-administered as a single dose orally

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Interventions

pomalidomide; Dexamethasone; daratumumab; Bortezomib; Lenalidomide

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Gang An, Professor

CONTACT

008613502181109; angang@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 12, 2025
• Study Start: September 12, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: September 22, 2025

Record last verified: 2025-05

Locations

CN (1)