QLS32015 combination therapy for relapsed or refractory multiple myeloma

A Multicenter, Open-Label Phase II Study to Evaluate QLS32015 Combination Therapy in the Treatment of Multiple Myeloma

This study will test whether the injected drug QLS32015 combined with approved myeloma medicines helps people whose multiple myeloma has come back or not responded to previous treatment.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Qilu Pharmaceutical Co., Ltd. (industry)
• Drugs / interventions: Daratumumab, CAR-T, chimeric antigen receptor, radiation
• Locations: 1 site (Tianjin)
• Trial ID: NCT07018050 on ClinicalTrials.gov

What this trial studies

This Phase II interventional study gives participants subcutaneous QLS32015 together with one of several backbone regimens to compare anti-myeloma activity across combinations. Regimens include QLS32015 with pomalidomide (usually with dexamethasone), QLS32015 with QL2109 or daratumumab (with or without pomalidomide), and QLS32015 with bortezomib plus lenalidomide. Eligible participants must have relapsed or refractory multiple myeloma with measurable disease by IMWG criteria and have received at least one prior line of therapy. The trial will compare response and disease control outcomes between the combination arms to identify promising regimens for further study.

Who should consider this trial

Good fit: Adults with relapsed or refractory multiple myeloma who have received at least one prior anti-myeloma therapy and have measurable disease by IMWG criteria are the intended candidates.

Not a fit: Patients with prior Grade 3 or higher cytokine release syndrome from T‑cell redirecting therapies, prior GPRC5D‑targeted therapy, or recent genetically modified adoptive cell therapy (e.g., CAR‑T or NK cell therapy) may be ineligible or less likely to benefit.

Why it matters

Potential benefit: If successful, these combinations could provide new effective treatment options that control disease in patients with relapsed or refractory multiple myeloma.

How similar studies have performed: Other GPRC5D‑targeting bispecific agents have shown promising activity in relapsed myeloma, but using QLS32015 in these specific combination regimens remains experimental.

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).

Where this trial is running

Tianjin

• Institute of Hematology & Blood Diseases Hospital — Tianjin, China (RECRUITING)

Study contacts

• Study coordinator: Gang An, Professor

Conditions: Relapsed or Refractory Multiple Myeloma