Actively Recruiting
A Novel CAR-T Combined Expression of IL-15 in the Treatment of Malignant Hematological Tumors
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
The is a multicenter, single arm, open label clinical study on the novel CAR-T combined expression of IL-15 in the treatment of malignant hematological tumors.Plan to recruit 45 subjects with malignant hematological tumors.
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanxi Bethune Hospital
Taiyuan, Shanxi, China, 030000
Actively Recruiting
Research Team
J
JIA WEI
CONTACT
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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