QLS4131 Combination Therapy in Malignant Plasma Cell Neoplasms

NCT07560449 | Not Yet Recruiting Phase 2

• 1 other identifier: QLS4131-202
• Study Type: interventional
• Target: 162
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Malignant Plasma Cell Neoplasms

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (4)

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.

Drug: QLS4131; Drug: QL2109; Drug: Pomalidomide; Drug: Lenalidomide; Drug: Dexamethasone

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.

Drug: QLS4131; Drug: QL2109; Drug: Dexamethasone

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.

Drug: QLS4131; Drug: Pomalidomide; Drug: Dexamethasone

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.

Drug: QLS4131; Drug: QL2109; Drug: Lenalidomide; Drug: Dexamethasone

Interventions

QLS4131 DRUG

QLS4131 will be administered subcutaneously.

QLS4131(SC) in combination with Pomalidomide; QLS4131(SC) in combination with QL2109; QLS4131(SC) in combination with QL2109 for injection and Lenalidomide; QLS4131(SC) in combination with QL2109, with or without Pomalidomide or Lenalidomide

QL2109 DRUG

QL2109 will be administered subcutaneously.

QLS4131(SC) in combination with QL2109; QLS4131(SC) in combination with QL2109 for injection and Lenalidomide; QLS4131(SC) in combination with QL2109, with or without Pomalidomide or Lenalidomide

Pomalidomide DRUG

Pomalidomide will be self-administered as a single dose orally.

QLS4131(SC) in combination with Pomalidomide; QLS4131(SC) in combination with QL2109, with or without Pomalidomide or Lenalidomide

Lenalidomide DRUG

Lenalidomide will be self-administered as a single dose orally.

QLS4131(SC) in combination with QL2109 for injection and Lenalidomide; QLS4131(SC) in combination with QL2109, with or without Pomalidomide or Lenalidomide

Dexamethasone DRUG

Dexamethasone will be administered orally or intravenously.

QLS4131(SC) in combination with Pomalidomide; QLS4131(SC) in combination with QL2109; QLS4131(SC) in combination with QL2109 for injection and Lenalidomide; QLS4131(SC) in combination with QL2109, with or without Pomalidomide or Lenalidomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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:
• 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).

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

MeSH Terms

Interventions

pomalidomide; Lenalidomide; Dexamethasone

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

YU HU, Doctor of Medicine (MD)

CONTACT

027-85726387; dr_huyu@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 1, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2030
• Last Updated: May 1, 2026

Record last verified: 2026-04