QLS32015 combination therapy for relapsed or refractory multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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);
  * Bispecific antibody therapy for multiple myeloma within 21 days or 5 half-lives (whichever is longer);
  * Cytotoxic therapy or monoclonal antibodies 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 it's running

• Institute of Hematology & Blood Diseases Hospital
  Tianjin, China Recruiting

Study contacts

• Study coordinator: Gang An, Professor
• Email: angang@ihcams.ac.cn
• Phone: 008613502181109

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• AZD4045 in Relapsed or Refractory Multiple Myeloma

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• QLS32015 versus pomalidomide+dexamethasone or selinexor+dexamethasone for relapsed or refractory multiple myeloma

  This will see if QLS32015 alone controls disease and is safe compared with pomalidomide+dexamethasone or selinexor+dexamethasone in adults with relapsed or refractory multiple myeloma who have had at least three prior treatments.

  Recruiting Phase 3 Qilu Pharmaceutical Co., Ltd. · Tianjin, Tianjin Municipality · NCT07138209

• mRNA-2808 for relapsed or refractory multiple myeloma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.