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Relapsed/Refractory Multiple Myeloma (RRMM)Early Phase 1QLS32015NCT07185477

A Single-arm Single-center Trial of Bridging GPRC5D/CD3 Bispecific Antibody Treatment With BCMA CAR-T Cell Therapy for Relapsed/Refractory Multiple Myeloma

A Early Phase 1 study testing QLS32015 in people with Relapsed/Refractory Multiple Myeloma (RRMM), run by Institute of Hematology & Blood Diseases Hospital, China.

Not yet recruiting

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

Official record
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Trial summary

This study is a prospective, single-arm, multicenter trial designed to evaluate the hematologic response rate and safety of GPRC5D/CD3 bispecific antibody bridging therapy prior to CAR-T cell infusion in patients with relapsed/refractory multiple myeloma (RRMM). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
QLS32015
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
15 Sep 2025to 31 May 2028
Phase
Early Phase 1
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

  • Voluntary Participation: Ability to understand and voluntarily sign the informed consent form (ICF).
  • Age ≥18 years.
  • Confirmed symptomatic MM diagnosis per the Chinese Guidelines for Diagnosis and Management of Multiple Myeloma (2022 Revision).
  • Relapsed/Refractory MM (RRMM) meeting one of the following:
  • Triple-class refractory RRMM: Resistant to ≥1 immunomodulatory drug (IMiD), ≥1 proteasome inhibitor (PI), and ≥1 anti-CD38 monoclonal antibody.
  • Penta-drug refractory RRMM: Resistant to ≥2 IMiDs, ≥2 PIs, and ≥1 anti-CD38 antibody.
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  • Secondary plasma cell leukemia (sPCL):
  • MM diagnosis per Chinese Guidelines (2022), plus Peripheral blood plasma cells ≥20% of leukocytes or absolute circulating plasma cells >2×10⁹/L.
  • Successful apheresis for CAR-T cell manufacturing.
  • ECOG performance status ≤3.
  • No active infections:
  • HBV-DNA negative, HCV-RNA negative, HIV negative.
  • Liver function:
  • Total bilirubin <1.5×ULN (<3×ULN for Gilbert's syndrome). AST/ALT <3×ULN.
  • Renal function: Calculated CrCl ≥30 mL/min (Cockcroft-Gault formula).
  • Baseline oxygen saturation >92% (room air).
  • Hematologic criteria (within 7 days of screening):
  • WBC ≥1.0×10⁹/L, ANC ≥1.0×10⁹/L, hemoglobin ≥70 g/L, and Platelets ≥75×10⁹/L (or ≥50×10⁹/L if bone marrow plasma cells ≥50%). Investigator discretion permitted for clinical justification. 12.Growth factor restrictions: 2-week washout required for erythropoietin, G-CSF, GM-CSF, or thrombopoietin agonists (e.g., eltrombopag).
  • 13.Reproductive requirements: Non-childbearing women eligible; Childbearing potential women: Negative serum/urine pregnancy test (β-hCG) at screening.
  • 14.Contraception: Males/females of reproductive potential must use effective contraception (per investigator judgment) during treatment and for ≥3 months post CAR-T infusion.
  • 15.Sperm donation prohibition: Males must refrain from sperm donation from screening until 90 days post-treatment.
  • 16.Compliance: Willing and able to complete study procedures and follow-up.

Who cannot join

  • Prior GPRC5D-targeted immunotherapy.
  • Investigator-assessed contraindications to GPRC5D×CD3 bispecific antibody therapy (e.g., severe cardiopulmonary diseases incompatible with treatment).
  • Grade >2 peripheral neuropathy or ≥grade 2 painful neuropathy at screening (regardless of current medication).
  • Known intolerance, hypersensitivity, or contraindication to GPRC5D×CD3 bispecific antibody components.
  • Initiation of bridging therapy for BCMA CAR-T cell treatment.
  • Unstable/active cardiovascular or cerebrovascular disease, including any of:
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  • Unstable angina, symptomatic myocardial ischemia, myocardial infarction, or coronary revascularization within 180 days prior to first dose.
  • Uncontrolled hypertension (>140/90 mmHg with historical readings >180/100 mmHg within 6 months).
  • Clinically significant uncontrolled arrhythmias (excluded: asymptomatic 1st-degree AV block or LAFB/RBBB).
  • LVEF <40% by echocardiography.
  • Stroke or intracranial hemorrhage within 12 months before screening.
  • Pre-treatment severe thrombotic events.
  • Active HIV infection or seropositivity.
  • Active HBV/HCV infection:
  • HBV: HBsAg(+) requires confirmed negative HBV-DNA PCR (allowed: if on antiviral therapy with confirmed suppression).
  • HCV: HCV Ab(+) requires negative HCV-RNA PCR.
  • Pregnancy or lactation.
  • Active gastrointestinal disorders affecting swallowing or drug absorption.
  • Major surgery within 2 weeks pre-enrollment or planned during study (excluded: kyphoplasty/vertebroplasty; allowed: local anesthesia procedures).
  • Live vaccines within 4 weeks before first study dose.
  • Active psychiatric/medical conditions impairing compliance/consent capacity per investigator judgment.
  • Contraindications to required concomitant medications/supportive care.
  • Any condition interfering with study procedures.
  • Inability/unwillingness to comply with protocol.

About this study

This study is a prospective, single-arm, multicenter trial designed to evaluate the hematologic response rate and safety of GPRC5D/CD3 bispecific antibody bridging therapy prior to CAR-T cell infusion in patients with relapsed/refractory multiple myeloma (RRMM).

Being tested
QLS32015
Medical subject headings
Multiple Myeloma

What participants receive

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

  • QLS32015Biological

    QLS32015 is a GPRC5D × CD3 bispecific antibody.

Study groups in NCT07185477
Study groupRoleWhat they receive
QLS32015ExperimentalNot described
Receives: Biological: QLS32015

What is being measured

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

  1. Overall Response Rate (ORR)

    The proportion of subjects achieving stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) after treatment with QLS32015 injection

    Measured: Minimum 2 years after infusion

  2. Safety and Tolerability

    The incidence of treatment-emergent adverse events (TEAES)

    Measured: Minimum 2 years after infusion

Secondary outcomes (4)

  1. Time to Response (TTR)

    Time from first BCMA×CD3 bispecific antibody infusion to first hematologic response，Depth of best hematologic response: The highest-level response achieved at any timepoint

    Measured: Minimum 2 years after infusion

  2. Duration of Response (DOR)

    Duration of response (DOR) was defined as the time from first documented hematologic response (≥ partial response [PR]) to disease progression or death due to progression, whichever occurred first

    Measured: Minimum 2 years after infusion

  3. Overall Survival (OS)

    Measured: Minimum 2 years after infusion

  4. Progression-Free Survival (PFS)

    Measured: Minimum 2 years after infusion

Timeline

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

  1. First posted22 Sep 2025
  2. Study start15 Sep 2025 (estimated)
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 May 2028 (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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07185477
Sponsor's protocol ID
IIT2025080
Other IDs
Qilu Pharmaceutical Co., Ltd.
Acronym
QLS32015
Status last verified
Sep 2025
First submitted
5 Sep 2025
Last updated
22 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing QLS32015 in people with Relapsed/Refractory Multiple Myeloma (RRMM), run by Institute of Hematology & Blood Diseases Hospital, China.

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 22 inclusion and 24 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 22 Sep 2025. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: Minimum 2 years after infusion). The study lists 2 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 NCT07185477.

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 22 Sep 2025.

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