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 range18 Years ā 80 Years
SexALL
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Inclusion criteria
ā. Able and willing to provide written informed consent and comply with the scheduled visits, study treatment, laboratory assessments, and other study procedures.
ā. 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.
ā. Age 18 to 80 years, inclusive.
ā. Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
ā. Estimated life expectancy \> 3 months from the date of signing the informed consent form.
ā. 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
ā. History within 1 year prior to signing the informed consent form of any of the following:
ā. Active graft-versus-host disease (GVHD) or requirement for systemic immunosuppressive therapy.
ā. 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.
ā. Active infection requiring systemic therapy or uncontrolled infection within 7 days prior to screening (excluding mild genitourinary or upper respiratory tract infections).
ā. Evidence of active viral or infectious disease as follows:
ā. 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).
ā. History of severe allergic reactions to biologic products.
ā. Any unstable systemic disease, as judged by the investigator, including but not limited to severe hepatic, renal, or metabolic disorders requiring medical treatment.