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Relapsed/Refractory Multiple MyelomaPhase 2NCT07509086

IL-15-Armored CAR-T Therapy in Relapsed or Refractory Multiple Myeloma and Plasma Cell Leukemia

A Phase 2 study testing IL-15-armored CAR-T cells in people with Relapsed/Refractory Multiple Myeloma and Plasma Cell Leukemia (PCL), run by The First Hospital of Jilin University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is an open-label, single-arm, Phase 2 study to evaluate the efficacy and safety of IL-15-armored chimeric antigen receptor T-cell (CAR-T) therapy in subjects with relapsed or refractory multiple myeloma and plasma cell leukemia. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
IL-15-armored CAR-T cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteChina
Study dates
29 Dec 2025to 15 Jul 2029
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able and willing to provide written informed consent and comply with the scheduled visits, study treatment, laboratory assessments, and other study procedures.
  • Clinically diagnosed relapsed or refractory multiple myeloma or plasma cell leukemia (PCL). Patients with persistent minimal residual disease (MRD) positivity or conversion from MRD-negative to MRD-positive status following induction and consolidation therapy are also eligible for enrollment.
  • Age 18 to 80 years, inclusive.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
  • Estimated life expectancy > 3 months from the date of signing the informed consent form.
  • Hemoglobin ≥ 60 g/L (transfusion permitted).
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  • Adequate organ function as defined below:
  • Creatinine clearance (CrCl) ≥ 40 mL/min, calculated using the Cockcroft-Gault formula;
  • Left ventricular ejection fraction (LVEF) ≥ 50%;
  • Oxygen saturation > 90% on room air;
  • Total bilirubin ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN.
  • Participants of childbearing potential must agree to use effective contraception prior to study enrollment and for at least 6 months after completion of study treatment. Participants who become pregnant or suspect pregnancy must notify the investigator immediately.

Who cannot join

  • History within 1 year prior to signing the informed consent form of any of the following:
  • New York Heart Association (NYHA) Class III or IV heart failure;
  • Myocardial infarction;
  • Cardiac angioplasty or stent placement;
  • Unstable angina;
  • Other clinically significant symptomatic cardiac disease;
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  • Active graft-versus-host disease (GVHD) or requirement for systemic immunosuppressive therapy.
  • History of other malignancies within 5 years prior to screening, except for adequately treated carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin, localized prostate cancer after radical surgery, or ductal carcinoma in situ of the breast after curative surgery.
  • Active infection requiring systemic therapy or uncontrolled infection within 7 days prior to screening (excluding mild genitourinary or upper respiratory tract infections).
  • Evidence of active viral or infectious disease as follows:
  • Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA above the lower limit of detection;
  • Positive hepatitis C virus (HCV) antibody with detectable HCV RNA;
  • Positive human immunodeficiency virus (HIV) antibody;
  • Positive Treponema pallidum particle agglutination assay (TPPA).
  • Participation in another clinical trial within 4 weeks prior to signing the informed consent form, or if the time from the last dose of an investigational drug to informed consent is less than 5 half-lives of that drug (whichever is longer).
  • History of severe allergic reactions to biologic products.
  • Any unstable systemic disease, as judged by the investigator, including but not limited to severe hepatic, renal, or metabolic disorders requiring medical treatment.
  • Pregnant or breastfeeding women; women planning to become pregnant within 2 years after cell infusion; or male participants whose partners plan to become pregnant within 2 years after cell infusion.
  • Any condition that, in the opinion of the investigator, may increase the participant's risk or interfere with study participation or interpretation of study results.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin, 130000

    FengYan Jin, MD, PhD, +8617843082307, fengyanjin@jlu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: A Clinical Study Evaluating the Safety and Efficacy of IL-15-armored Novel CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma and Plasma Cell Leukemia

This is an open-label, single-arm, Phase 2 study to evaluate the efficacy and safety of IL-15-armored chimeric antigen receptor T-cell (CAR-T) therapy in subjects with relapsed or refractory multiple myeloma and plasma cell leukemia.

Read the detailed description

This is an open-label, single-arm, Phase 2 study to evaluate the efficacy and safety of IL-15-armored CAR-T therapy in subjects with relapsed or refractory (R/R) multiple myeloma (MM) and plasma cell leukemia (PCL). Subjects with persistent measurable residual disease (MRD) positivity or conversion from MRD-negative to MRD-positive status are also eligible.

IL-15-armored CAR-T cells are autologous T lymphocytes genetically engineered to express a chimeric antigen receptor along with IL-15. The co-expression of IL-15 is intended to enhance in vivo expansion, persistence, and anti-tumor activity.

Subjects will undergo leukapheresis for CAR-T cell manufacturing, followed by lymphodepletion prior to infusion. Bridging therapy is permitted at the investigator's discretion, and radiotherapy is allowed before infusion for subjects with extramedullary disease.

After infusion, the efficacy and safety will be evaluated by the investigators.

Exploratory Objectives and Correlative Studies:

In addition to the primary efficacy and safety evaluations, exploratory analyses will be conducted to investigate clinical, biological, and treatment-related factors associated with treatment response and severe toxicity, with the aim of developing predictive models.

Multi-omics approaches, including single-cell sequencing, bulk RNA sequencing, and spatial transcriptomics, will be employed to characterize the dynamics of the tumor microenvironment.

Circulating tumor DNA (ctDNA) will be longitudinally collected from baseline through post-infusion follow-up. The associations between ctDNA dynamics and clinical outcomes will be assessed.

The clinical efficacy and biological mechanisms of radiotherapy (including site-directed radiotherapy and low-dose intestinal irradiation) in combination with CAR-T cell therapy will also be explored.

Being tested
IL-15-armored CAR-T cells
Keywords
Relapsed/Refractory Multiple Myeloma, Plasma Cell Leukemia, IL-15-armored CAR-T
Medical subject headings
Multiple Myeloma, Leukemia, Plasma Cell

What participants receive

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

  • IL-15-armored CAR-T cellsBiological

    BCMA-targeted: 1.0/1.5/2.0 × 10^6 CAR-T cells; CD19/BCMA dual-targeted: 1.0/1.5/2.0 × 10^6 CAR-T cells; GPRC5D-targeted: 1.0/2.0/3.0 × 10^6 CAR-T cells.

Study groups in NCT07509086
Study groupRoleWhat they receive
IL-15 armored CAR-T cellsExperimentalBridging therapy is permitted at the investigator's discretion. Radiotherapy is permitted before infusion for subjects with extramedullary disease. Lymphodepletion with fludarabine plus cyclophosphamide will be performed prior to CAR-T cells infusion.
Receives: Biological: IL-15-armored CAR-T cells

What is being measured

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

  1. Overall response rate (ORR)

    Percentage of participants with presence of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). ORR assessment will be based on International Myeloma Working Group (IMWG) response criteria.

    Measured: From infusion to 12 months

Secondary outcomes (11)

  1. Complete Response Rate

    Percentage of participants who achieved CR or sCR according to IMWG Uniform Response Criteria for Multiple Myeloma

    Measured: From infusion to 12 months

  2. MRD-negative rate

    Achieving measurable residual disease (MRD) negativity, as determined by multiparameter flow cytometry (MFC) or next-generation sequencing (NGS) after CAR-T cells infusion.

    Measured: From infusion to 12 months

  3. CR/MRD-negative rate

    Percentage of participants who achieved both CR and MRD negativity with a sensitivity of 10^-4 or better within 12 months post infusion.

    Measured: From infusion to 12 months

  4. Time to Response

    Time from infusion to first documentation of response of PR or better.

    Measured: From infusion to 12 months

  5. Duration of Response (DOR)

    Time from first documentation of PR or better to first documentation of disease progression or death from any cause, whichever occurs first.

    Measured: From first documentation of response through the end of follow-up (up to 24 months)

  6. Progression-free survival (PFS)

    Time from first infusion to first documentation of progressive disease (PD), or death due to any cause, whichever occurs first.

    Measured: From infusion through the end of follow-up (up to 24 months)

  7. Overall Survival (OS)

    Time from first infusion to time of death due to any cause.

    Measured: From infusion through the end of follow-up (up to 24 months)

  8. Cmax

    The maximum transgene level at Tmax.

    Measured: From infusion to 12 months

  9. Tmax

    The time of maximum observed transgene level, obtained directly from the observed transgene level-time.

    Measured: From infusion to 12 months

  10. AUC (0-180 days)

    The area under the curve (AUC) of the transgene level from the time of dosing to Day 180.

    Measured: at Day 180 post infusion

  11. Number of Participants With Safety Related Events

    Number of participants with adverse events (AEs), adverse events of special interest (AESI), serious adverse events (SAEs), cytokine release syndrome, neurotoxicity, infection, and clinically significant laboratory abnormalities.

    Measured: From enrollment through the end of follow-up (up to 24 months)

Timeline

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

  1. First posted3 Apr 2026
  2. Study start29 Dec 2025
  3. Primary completion15 Jul 2028 (estimated)
  4. Study completion15 Jul 2029 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07509086
Sponsor's protocol ID
MM IL-15-Armored CAR-T
Status last verified
Mar 2026
First submitted
21 Feb 2026
Last updated
3 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IL-15-armored CAR-T cells in people with Relapsed/Refractory Multiple Myeloma and Plasma Cell Leukemia (PCL), run by The First Hospital of Jilin University at 1 site in 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 12 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR) (time frame: From infusion to 12 months). 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 NCT07509086.

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 3 Apr 2026.

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