QLS4131 Combination Therapy in Malignant Plasma Cell Neoplasms
ConditionMalignant Plasma Cell Neoplasms
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorQilu Pharmaceutical Co., Ltd.
About this trial
The purpose of the study is to compare the efficacy of QLS4131(SC) in combination with QL2109, with or without pomalidomide or lenalidomide, and QLS4131 (SC) in combination with QL2109, and QLS4131 (SC) in combination with Pomalidomide, and QLS4131(SC) in combination with QL2109 and Lenalidomide.
Eligibility criteria
Qualifiers
Serum M-protein ≥0.5 g/dL (5 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.
Disqualifiers
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);
Previous treatment with BCMA/GPRC5D/CD3-targeted therapy;
Cytotoxic therapy or small-molecule targeted therapy within 2 weeks or 5 half-lives, If the half-life is unknown, the washout period shall be 2 weeks (whichever is longer);
Immunomodulatory drug therapy within 7 days
Trial design
Treatments tested in this trial
- QLS4131
- QL2109
- Pomalidomide
- Lenalidomide
- Dexamethasone
Treatment groups
162 Participants
are divided into 4 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov