Malignant Plasma Cell Neoplasms
Conditions
Brief summary
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.
Interventions
DRUGQLS4131
QLS4131 will be administered subcutaneously.
DRUGQL2109
QL2109 will be administered subcutaneously.
DRUGPomalidomide
Pomalidomide will be self-administered as a single dose orally.
DRUGLenalidomide
Lenalidomide will be self-administered as a single dose orally.
DRUGDexamethasone
Dexamethasone will be administered orally or intravenously.
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Diagnosis of multiple myeloma confirmed according to the 2016 International Myeloma Working Group (IMWG) diagnostic criteria, or diagnosis of plasma cell leukemia and primary light-chain amyloidosis confirmed in accordance with relevant guidelines.; For patients with multiple myeloma and plasma cell leukemia, measurable disease at screening is defined as meeting any one of the following: * 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. For patients with light-chain amyloidosis:Measurable disease is defined as Involved serum free light chain ≥ 50 mg/L with an abnormal light chain ratio,ordifference between involved and uninvolved serum free light chains (dFLC) ≥ 50 mg/L.
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); * Patients who received any of the following prior anti-tumor therapies before the first dose of investigational productt: 1. Previous treatment with BCMA/GPRC5D/CD3-targeted therapy; 2. Received any anti-tumor therapy within 4 weeks prior to the first dose, except for the following circumstances: * 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 * Genetically modified adoptive cell therapy within 3 months.; * Traditional Chinese medicine with anti-tumor indications within 14 days.; * Radiotherapy within 14 days * Prior intolerance to Pomalidomide (applies to treatment cohorts containing Pomalidomide); * Prior intolerance to Lenalidomide (applies to treatment cohorts containing Lenalidomide); * Prior intolerance to QL2109 (applies to treatment cohorts containing QL2109).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DLT | From time of the first dose of QLS4131 to end of DLT period (28 days) | To evaluate the tolerability and safety of subcutaneous administration of QLS4131 for Injection in combination with other agents in patients with malignant plasma cell neoplasms |
| MTD | Up to 2 years | To determine the maximum tolerated dose (MTD) |
| 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. |
Contacts
CONTACTYU HU, Doctor of Medicine (MD)
Outcome results
None listed