Actively Recruiting
A Multicenter, Single Arm, Open Label Clinical Study on Novel CAR-T Therapy Expressing IL-15 for Malignant Hematological Tumors
Led by Shanxi Bethune Hospital · Updated on 2025-01-20
45
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a new CAR-T therapy that includes IL-15 expression to treat malignant blood cancers such as acute lymphocytic leukemia, non-Hodgkin lymphoma, and relapsed or refractory multiple myeloma. The main goal is to assess the safety and effectiveness of this treatment. Additionally, the study aims to understand how long the CAR-T cells survive in the body and how they activate and multiply. Participants will receive CAR-T cells infused intravenously at doses tailored to their specific blood cancer type, ranging from 0.5 to 5 million CAR-positive T cells per kilogram of body weight. The infusion is given using a blood transfusion device with a filter and saline rinsing. This single-arm, open-label study plans to enroll 45 patients and will monitor responses and survival following treatment. During the study, researchers will monitor the CAR-T cells' survival in the body for six months and assess antitumor effects within 28 days after infusion. They will also track longer-term outcomes such as disease-free survival and overall survival over three years. Participants will undergo regular clinical visits, laboratory tests, and evaluations to measure treatment impact and safety throughout the study period.
CONDITIONS
Brief 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 willingness to follow study procedures
- Diagnosis of CD19 and/or CD22, BCMA-positive malignant hematological tumors
- Age between 15 and 80 years old
- Recurrent or refractory hematologic malignancies after standard and salvage chemotherapy, or minimal residual lesions after treatment, or recurrence after stem cell transplantation
- Estimated survival of at least 12 weeks
- Good heart, liver, and kidney function including serum creatinine ≤ 1.5 mg/dL, ALT/AST ≤ 2.5 times normal limit, total bilirubin ≤ 1.5 mg/dL
- Cardiac ejection fraction ≥ 50% and no significant pericardial effusion
- ECOG performance status 0 to 3
- Able to understand and voluntarily sign informed consent (guardian consent for children)
You will not qualify if you...
- Heart failure NYHA Class greater than III, recent major heart events within one year, or QTc interval > 480 ms
- 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
- Positive active hepatitis B or C infection, HIV, CMV DNA, or syphilis antibodies
- Participation in another clinical trial within 4 weeks or recent drug half-lives
- Severe allergy to biological products
- Unstable systemic diseases requiring medical treatment
- Pregnant or lactating women or those planning pregnancy within 2 years after cell transfusion
- Any condition that may increase risk or interfere with study results as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or discontinuation
Participants receive the novel CAR-T therapy co-expressing IL-15 through intravenous infusion following dose guidelines based on their specific hematological malignancy.
1 infusion visit with possible additional monitoring visits during treatment period
Duration - Up to 3 years
Participants are monitored for safety, antitumor effects, and the in vivo survival of CAR-T cells after treatment.
Multiple follow-up visits over 3 years
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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