Actively Recruiting
IL-15-Armored CAR-T Therapy in Relapsed or Refractory Multiple Myeloma and Plasma Cell Leukemia
Led by The First Hospital of Jilin University · Updated on 2026-04-03
25
Participants Needed
1
Research Sites
184 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
IL-15-Armored CAR-T Therapy in Relapsed or Refractory Multiple Myeloma and Plasma Cell Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent and comply with study procedures.
- Diagnosed with relapsed or refractory multiple myeloma or plasma cell leukemia, including patients with persistent or converting measurable residual disease.
- Age between 18 and 80 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3.
- Estimated life expectancy greater than 3 months.
- Hemoglobin level of at least 60 g/L (transfusion allowed).
- Adequate organ function including creatinine clearance of at least 40 mL/min, left ventricular ejection fraction of at least 50%, oxygen saturation above 90% on room air, and liver enzymes within defined limits.
- Agreement to use effective contraception before enrollment and for 6 months after treatment completion if of childbearing potential.
You will not qualify if you...
- History within 1 year of severe heart conditions such as NYHA Class III or IV heart failure, myocardial infarction, cardiac angioplasty or stent placement, unstable angina, or other significant symptomatic cardiac disease.
- Active graft-versus-host disease or requiring systemic immunosuppressive therapy.
- History of other cancers within 5 years except certain treated localized cancers.
- Active or uncontrolled infection requiring systemic treatment.
- Evidence of active viral infections including hepatitis B or C, HIV, or syphilis.
- Participation in another clinical trial within 4 weeks or less than 5 half-lives since last investigational drug dose.
- History of severe allergic reactions to biologic products.
- Any unstable systemic disease requiring treatment.
- Pregnant or breastfeeding women, or those planning pregnancy within 2 years after treatment; male participants with partners planning pregnancy within 2 years.
- Any condition that may increase risk or interfere with study participation as judged by the investigator.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Hospital of Jilin University
Changchun, Jilin, China, 130000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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