Actively Recruiting
Study of a New CAR-T Therapy Including IL-15 for Treating Malignant Blood Cancers A Multicenter, Single Arm, Open Label Clinical Trial
Led by Shanxi Bethune Hospital · Updated on 2025-01-20
45
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new CAR-T cell therapy that includes IL-15 expression for treating malignant blood cancers such as acute lymphocytic leukemia, non-Hodgkin lymphoma, and relapsed or refractory multiple myeloma. This multicenter, single-arm, open-label clinical trial aims to assess the safety and effectiveness of this novel treatment. It also seeks to study how long the modified CAR-T cells survive and how they activate and multiply in the body. The treatment involves intravenous infusion of chimeric antigen receptor gene-modified T cells at a controlled rate using a blood transfusion device with a filter. Before infusion, the equipment is rinsed with saline to prepare. The study plans to enroll 45 participants who meet specific criteria related to their blood cancer diagnosis and previous treatments. Participants will be closely monitored for up to six months to track the survival of the CAR-T cells in their bodies and for 28 days to observe the anti-tumor effects following CAR-T cell reinfusion. The study involves scheduled visits, laboratory tests, and other procedures to evaluate treatment responses and safety. Researchers will collect data on heart, liver, and kidney function and observe for any adverse events throughout the study period.
CONDITIONS
Official Title
A Novel CAR-T Combined Expression of IL-15 in the Treatment of Malignant Hematological Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and willing to comply with study procedures
- Diagnosed by pathology or flow cytometry with CD19 and/or CD22, BCMA-positive hematological malignancies
- Age between 15 and 80 years old
- Have one of the following: recurrent or refractory malignancy after one standard chemotherapy and one salvage regimen; minimal residual disease after these treatments; or recurrence after stem cell transplantation
- Estimated survival of at least 12 weeks
- Good heart, liver, and kidney function (serum creatinine 3 1.5 mg/dL, ALT/AST 3 2.5 times upper limit of normal, total bilirubin 3 1.5 mg/dL)
- Cardiac ejection fraction 3 50%, no severe pericardial effusion
- ECOG performance status 0 to 3
- Able to understand and voluntarily sign informed consent (or guardian if participant is a child)
You will not qualify if you...
- New York Heart Association (NYHA) class III or higher heart failure, recent serious heart conditions in past year, or QTc interval >480ms at screening
- Active graft-versus-host disease or need for immunosuppressants
- Other malignancies within 5 years except certain treated cancers
- Active or uncontrolled infection requiring systemic treatment within 7 days before screening
- Positive for hepatitis B with detectable virus DNA, hepatitis C with detectable RNA, HIV, cytomegalovirus DNA, or syphilis antibody
- Participation in another clinical trial within 4 weeks before consent or within 5 half-lives of previous trial drug
- History of severe allergy to biological products
- Unstable systemic diseases including severe liver, kidney, or metabolic diseases
- Pregnant or breastfeeding women, or those planning pregnancy within 2 years after cell infusion
- Any condition increasing risk or interfering with study as judged by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanxi Bethune Hospital
Taiyuan, Shanxi, China, 030000
Actively Recruiting
Research Team
J
JIA WEI
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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