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Malignant Plasma Cell NeoplasmsPhase 2NCT07560449

QLS4131 Combination Therapy in Malignant Plasma Cell Neoplasms

A Phase 2 study testing QLS4131, QL2109 and Pomalidomide in people with Malignant Plasma Cell Neoplasms, run by Qilu Pharmaceutical Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Plasma Cell Neoplasms
What is being tested?
QLS4131, QL2109 and Pomalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
162 participants
Where
No sites listed yet
Study dates
Jun 2026to Jun 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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).

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

YU HU, Doctor of Medicine (MD) contact

027-85726387

dr_huyu@126.com

About this study

Official title: A Multicenter, Open-Label Phase II Study to Evaluate QLS4131 Combination Therapy in the Treatment of Malignant Plasma Cell Neoplasms

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.

Being tested
QLS4131, QL2109, Pomalidomide, Lenalidomide, Dexamethasone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QLS4131Drug

    QLS4131 will be administered subcutaneously.

  • QL2109Drug

    QL2109 will be administered subcutaneously.

  • PomalidomideDrug

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

  • LenalidomideDrug

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

  • DexamethasoneDrug

    Dexamethasone will be administered orally or intravenously.

Study groups in NCT07560449
Study groupRoleWhat they receive
QLS4131(SC) in combination with QL2109, with or without Pomalidomide or LenalidomideExperimentalParticipants 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.
Receives: Drug: QLS4131; Drug: QL2109; Drug: Pomalidomide; Drug: Lenalidomide; Drug: Dexamethasone
QLS4131(SC) in combination with QL2109ExperimentalParticipants will receive QLS4131 and QL2109 as SC injections; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
Receives: Drug: QLS4131; Drug: QL2109; Drug: Dexamethasone
QLS4131(SC) in combination with PomalidomideExperimentalParticipants 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.
Receives: Drug: QLS4131; Drug: Pomalidomide; Drug: Dexamethasone
QLS4131(SC) in combination with QL2109 for injection and LenalidomideExperimentalParticipants 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.
Receives: Drug: QLS4131; Drug: QL2109; Drug: Lenalidomide; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From time of the first dose of QLS4131 to end of DLT period (28 days)

  2. MTD

    To determine the maximum tolerated dose (MTD)

    Measured: 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.

    Measured: 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.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
162 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07560449
Sponsor's protocol ID
QLS4131-202
Status last verified
Apr 2026
First submitted
21 Apr 2026
Last updated
1 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing QLS4131, QL2109 and Pomalidomide in people with Malignant Plasma Cell Neoplasms, run by Qilu Pharmaceutical Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact YU HU, Doctor of Medicine (MD) (027-85726387, dr_huyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT (time frame: From time of the first dose of QLS4131 to end of DLT period (28 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07560449.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

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