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

Phase 2

Not yet recruiting

• Conditions: Relapsed or Refractory Multiple Myeloma
• Interventions: Drug: QLS32015; Drug: Pomalidomide; Drug: Dexamethasone; Drug: QL2109 or Daratumumab; Drug: Bortezomib; Drug: Lenalidomide

• Registration Number: NCT07018050
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-06-04
• Study First Submitted QC: 2025-06-04
• Last Update Submitted: 2025-06-04
• Study First Posted: 2025-06-12
• Last Update Posted: 2025-06-12
• Study Start: 2025-07
• Primary Completion: 2027-11
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QLS32015(SC) in combination with Pomalidomide	QLS32015	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.
QLS32015(SC) in combination with Pomalidomide	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.
QLS32015(SC) in combination with QL2109 or Daratumumab.	Dexamethasone	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.
QLS32015(SC) in combination with Pomalidomide	Dexamethasone	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.
QLS32015(SC) in combination with QL2109 or Daratumumab.	QLS32015	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.
QLS32015(SC) in combination with QL2109 or Daratumumab.	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.
QLS32015(SC) in combination with QL2109 or Daratumumab and Pomalidomide	QLS32015	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
QLS32015(SC) in combination with QL2109 or Daratumumab and Pomalidomide	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
QLS32015(SC) in combination with QL2109 or Daratumumab and Pomalidomide	Dexamethasone	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
QLS32015(SC) in combination with QL2109 or Daratumumab and Pomalidomide	QL2109 or Daratumumab	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
QLS32015(SC) in combination with Bortezomib for injection and Lenalidomide	QLS32015	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
QLS32015(SC) in combination with Bortezomib for injection and Lenalidomide	Dexamethasone	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
QLS32015(SC) in combination with Bortezomib for injection and Lenalidomide	Bortezomib	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
QLS32015(SC) in combination with Bortezomib for injection and Lenalidomide	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

Primary Outcome Measures

Name	Time	Method
ORR (Partial Response [PR] or Better)	Up to 2 years	Overall response (PR or better) is defined as percentage of participants who have a PR or better per International Myeloma Working Group (IMWG) criteria
Overall Minimal Residual Disease (MRD)	Up to 2 years	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

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	Up to 2 years	PFS is defined as time from the date of randomization to the first documentation of disease progression, or death due to any cause, whichever is reported first

Trial Locations

Locations (1)

Institute of Hematology & Blood Diseases Hospital; 🇨🇳 Tianjin, China