B-cell Acute Lymphoblastic LeukemiaB-cell LymphomaDiffuse Large B Cell Lymphoma
Investigational drug(s) / intervention(s)
CD19/CD22-bispecific CAR-T cells
CD19/CD22-bispecific CAR-T cells: CD19/CD22-bispecific CAR-T cells were infused at the same day with 2×10e6/kg and 1×10e6/kg dosage, respectively.
Study summary
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.
Eligibility
Sex
ALL
Min age
14 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria:
* 14 years to 85 years, expected survival \> 3 months;
* CD19/CD22 positive B-cell lymphoma or B-ALL;
* relapsed or refractory to standard first-line treatment;
* ECOG-PS score=0-2;
* Having at least one measurable lesions;
* Cardiac function: 1-2 levels;
* Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN;
* kidney: Cr≤1.25ULN;
* bone marrow: WBC ≥ 3.0×10e9/L, Hb ≥80 g/L, PLT ≥ 50×10e9/L;
* No serious allergic constitution;
* No other serious diseases that conflicts with the clinical program;
* No other cancer history;
* No serious mental disorder;
* Informed consent is signed by a subject or his lineal relation.
Exclusion Criteria:
* Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test);
* Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
* Active hepatitis B or hepatitis C infection;
* Recent or current use of glucocorticoid or other immunosuppressor;
* With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
* Participate in other clinical research in the past three months;
* previously treatment with any gene therapy products;
* Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results.
Primary outcome measure(s)
Best ORR — From the day of CAR-T cells infusion to 3 months post-CAR-T cells infusion Overall response rate means sum of complete response rate and partial response rate
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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