Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • QLS4131

    Drug

    QLS4131 will be administered subcutaneously.

  • 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.

Treatment groups

162 Participants
are divided into 4 treatment groups
Group A: QLS4131(SC) in combination with QL2109, with or without Pomalidomide or LenalidomideExperimental treatment 5 interventions
Group B: QLS4131(SC) in combination with QL2109Experimental treatment 3 interventions
Group C: QLS4131(SC) in combination with PomalidomideExperimental treatment 3 interventions
Group D: QLS4131(SC) in combination with QL2109 for injection and LenalidomideExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
From time of the first dose of QLS4131 to end of DLT period (28 days)
2

MTD

To determine the maximum tolerated dose (MTD)

Time frame
Up to 2 years
3

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.

Time frame
Up to 2 years
4

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.

Time frame
Up to 2 years

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qilu Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: