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

Qilu Pharmaceutical

Status and phase: Enrolling; Phase 2

Conditions: Relapsed or Refractory Multiple Myeloma

Treatments: Drug: Pomalidomide; Drug: QLS32015; Drug: Bortezomib; Drug: Dexamethasone; Drug: Lenalidomide; Drug: QL2109 or Daratumumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT07018050

QLS32015-202

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 4 patient groups

QLS32015(SC) in combination with Pomalidomide

Experimental group

Description:

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.

Treatment:

Drug: Dexamethasone

Drug: Pomalidomide

Drug: QLS32015

QLS32015(SC) in combination with QL2109 or Daratumumab.

Experimental group

Description:

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.

Treatment:

Drug: QL2109 or Daratumumab

Drug: Dexamethasone

Drug: QLS32015

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

Experimental group

Description:

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

Treatment:

Drug: QL2109 or Daratumumab

Drug: Dexamethasone

Drug: Pomalidomide

Drug: QLS32015

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

Experimental group

Description:

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

Treatment:

Drug: Lenalidomide

Drug: Dexamethasone

Drug: Bortezomib

Drug: QLS32015