Actively Recruiting
CD19/CD22 Bispecific CAR-T Cell Therapy for Relapsed/Refractory B-cell Lymphoma or Acute Lymphoblastic Leukemia
Led by Beijing Tongren Hospital · Updated on 2023-10-13
100
Participants Needed
1
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
CAR-T cell therapy targeting CD19 has been shown to be effective in heavily-pretreated B-cell ALL or NHL, but relapses post-CAR-T are common, and CD19 antigen loss is one of the reasons. Thus, we supposed that CD19/CD22 bispecific CAR-T cell therapy would be more effective and less relapses would occur in B-ALL or NHL. In this prospective phase 2 clinical trial, we aim to explore the efficacy and safety of CD19/CD22 bispecific CAR-T cell therapy in relapsed/refractory B-ALL or Large B cell lymphoma.
CONDITIONS
Official Title
CD19/CD22 Bispecific CAR-T Cell Therapy for Relapsed/Refractory B-cell Lymphoma or Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 14 and 85 years with expected survival longer than 3 months
- Diagnosed with CD19/CD22 positive B-cell lymphoma or B-cell acute lymphoblastic leukemia
- Relapsed or refractory to standard first-line treatment
- ECOG performance status score between 0 and 2
- At least one measurable lesion
- Cardiac function rated as level 1 or 2
- Liver tests within these limits: total bilirubin ≤3 times upper limit of normal, AST ≤2.5 times upper limit, ALT ≤2.5 times upper limit
- Kidney function with creatinine ≤1.25 times upper limit
- Bone marrow function with white blood cell count ≥3.0×10⁹/L, hemoglobin ≥80 g/L, platelets ≥50×10⁹/L
- No serious allergies
- No other serious diseases conflicting with the study
- No history of other cancers
- No serious mental disorders
- Signed informed consent by participant or legal relative
You will not qualify if you...
- Pregnant or breastfeeding women; females of reproductive potential must test negative for pregnancy
- Uncontrolled active infections, including HIV, syphilis, active hepatitis B or C
- Recent or current use of glucocorticoids or other immunosuppressive drugs
- Severe cardiac, liver, or kidney failure, diabetes, or other serious diseases
- Participation in another clinical trial within the past three months
- Previous treatment with any gene therapy products
- Any condition the researchers believe makes participation unsuitable or could affect study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Liang Wang
Beijing, Beijing Municipality, China, 100730
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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