Supercharged immune cells take on Hard-to-Treat blood cancer
NCT ID NCT07509086
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new type of CAR-T cell therapy, boosted with IL-15, in 25 people with multiple myeloma or plasma cell leukemia that has come back or not responded to treatment. The therapy uses the patient's own immune cells, engineered to target cancer cells. The goal is to see if it can shrink tumors and improve response rates.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- IL-15-armored CAR-T cells (immune cells engineered to target cancer)
- What this could lead to
- If successful, this could offer a new treatment option for people with hard-to-treat multiple myeloma or plasma cell leukemia.
- What could go wrong
- This is a small, early-phase trial with only 25 participants, so results may not apply to everyone. CAR-T therapy can cause serious side effects like cytokine release syndrome.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Hospital of Jilin University
RECRUITINGChangchun, Jilin, 130000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can engineered cells beat blood cancers that Won't quit?
- Can a tropical tea shrink blood cancers?
- Engineered immune cells take aim at Hard-to-Treat myeloma
- Can engineered immune cells outsmart Treatment-Resistant myeloma?
- Can a lower dose of a myeloma drug keep the disease in check with fewer side effects?
- A pre-treatment pill may supercharge cancer-fighting immune cells