IL-15-Armored CAR-T Therapy in Relapsed or Refractory Multiple Myeloma and Plasma Cell Leukemia (NCT07509086) | Clinical Trial Compass
RecruitingPhase 2
IL-15-Armored CAR-T Therapy in Relapsed or Refractory Multiple Myeloma and Plasma Cell Leukemia
China25 participantsStarted 2025-12-29
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 2 trial testing an IL-15-armored CAR-T therapy — what does it mean that it's already in Phase 2, and does that give us more safety and effectiveness data compared to earlier-phase CAR-T studies I might have seen?
2The trial is measuring overall response rate as its main goal — based on what's been seen so far, is there any early signal about how well this approach is working for patients with my specific situation, relapsed or refractory multiple myeloma versus plasma cell leukemia?
3CAR-T therapies can involve serious side effects like cytokine release syndrome — does the IL-15 'armoring' in this particular therapy change the risk or severity of those side effects compared to standard CAR-T treatments you've seen?
4Given that this trial is actively recruiting right now, how would the timing and logistics of going through CAR-T treatment — including any required hospitalization or monitoring period — fit with my current condition and treatment schedule?
5Before considering this trial, should I exhaust any remaining standard treatment options first, or is my situation at a point where an investigational therapy like this one might actually be the better path to discuss?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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
. History within 1 year prior to signing the informed consent form of any of the following:
. 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:
. 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.