Clinical trial NCT07018050: Phase II Study of QLS32015 Combination Therapy in the Treatment of Multiple Myeloma
Official title: A Multicenter, Open-Label Phase II Study to Evaluate QLS32015 Combination Therapy in the Treatment of Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Relapsed or Refractory Multiple Myeloma
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-06-12
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: ORR (Partial Response [PR] or Better)
timeFrame: Up to 2 years
measure: Overall Minimal Residual Disease (MRD)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital
Study officials:
References: