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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLS4131(SC) in combination with QL2109, with or without Pomalidomide or Lenalidomide | Experimental | Participants will receive QLS4131 and QL2109 as SC injections; Pomalidomide/ Lenalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug. |
|
| QLS4131(SC) in combination with QL2109 | Experimental | Participants will receive QLS4131 and QL2109 as SC injections; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug. |
|
| QLS4131(SC) in combination with Pomalidomide | Experimental | Participants will receive QLS4131 as SC injections; Pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug. |
|
| QLS4131(SC) in combination with QL2109 for injection and Lenalidomide | Experimental | Participants will receive QLS4131 and QL2109 as SC injections; Lenalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLS4131 | Drug | QLS4131 will be administered subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| DLT | 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 | From time of the first dose of QLS4131 to end of DLT period (28 days) |
| MTD | To determine the maximum tolerated dose (MTD) | Up to 2 years |
| ORR (Partial Response [PR] or Better) | Overall response (PR or better) is defined as percentage of participants who have a PR or better per International Myeloma Working Group (IMWG) criteria. | Up to 2 years |
| Overall Minimal Residual Disease (MRD) | 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. | Up to 2 years |
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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:
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:
Previous treatment with BCMA/GPRC5D/CD3-targeted therapy;
Received any anti-tumor therapy within 4 weeks prior to the first dose, except for the following circumstances:
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).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| YU HU, Doctor of Medicine (MD) | Contact | 027-85726387 | dr_huyu@126.com |
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| ID | Term |
|---|---|
| C467566 | pomalidomide |
| D000077269 | Lenalidomide |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| QL2109 | Drug | QL2109 will be administered subcutaneously. |
|
| Pomalidomide | Drug | Pomalidomide will be self-administered as a single dose orally. |
|
| Lenalidomide | Drug | Lenalidomide will be self-administered as a single dose orally. |
|
| Dexamethasone | Drug | Dexamethasone will be administered orally or intravenously. |
|
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |