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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

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

IL-15-Armored CAR-T Therapy in Relapsed or Refractory Multiple Myeloma and Plasma Cell Leukemia (NCT07509086) is a Phase 2 interventional studying Relapsed/Refractory Multiple Myeloma and Plasma Cell Leukemia (PCL), sponsored by The First Hospital of Jilin University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Relapsed/Refractory Multiple Myeloma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 25 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Able and willing to provide written willing to sign a consent form and comply with the scheduled visits, study treatment, laboratory assessments, and other study procedures. 2. 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. 3. Age 18 to 80 years, inclusive. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-3. 5. Estimated life expectancy \> 3 months from the date of signing the willing to sign a consent form form. 6. blood count (hemoglobin) at least 60 g/L (transfusion permitted). 7. your organs (liver, kidneys, etc.) are working well enough based on blood tests 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. 8. 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 Should NOT Join This Trial: 1. History within 1 year prior to signing the willing to sign a consent form 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; 2. Active graft-versus-host disease (GVHD) or requirement for systemic immunosuppressive therapy. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Able and willing to provide written informed consent and comply with the scheduled visits, study treatment, laboratory assessments, and other study procedures. 2. 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. 3. Age 18 to 80 years, inclusive. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-3. 5. Estimated life expectancy \> 3 months from the date of signing the informed consent form. 6. Hemoglobin ≥ 60 g/L (transfusion permitted). 7. 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. 8. 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. Exclusion Criteria: 1. 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; 2. Active graft-versus-host disease (GVHD) or requirement for systemic immunosuppressive therapy. 3. 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. 4. Active infection requiring systemic therapy or uncontrolled infection within 7 days prior to screening (excluding mild genitourinary or upper respiratory tract infections). 5. 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). 6. 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). 7. History of severe allergic reactions to biologic products. 8. Any unstable systemic disease, as judged by the investigator, including but not limited to severe hepatic, renal, or metabolic disorders requiring medical treatment. 9. 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. 10. 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.

Treatments Being Tested

BIOLOGICAL

IL-15-armored CAR-T cells

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The First Hospital of Jilin University
Changchun, Jilin, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07509086), the sponsor (The First Hospital of Jilin University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07509086 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07509086?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07509086?

Contact information for this trial may be available directly on the ClinicalTrials.gov record. Click "View on ClinicalTrials.gov" in the sidebar for the official source. Always discuss any potential trial with your doctor before contacting the study site.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07509086. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07509086. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.