CD19/CD22 bispecific CAR-T cells: CD19/CD22-bispecific CAR-T cells were infused at the dosage of 2×10e6/kg
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, the investigators supposed that CD19/CD22 bispecific CAR-T cell therapy would be more effective and less relapses would occur in B- NHL. In this prospective phase 2 clinical trial, the investigators aim to explore the efficacy and safety of CD19/CD22 bispecific CAR-T cell therapy in relapsed/refractory 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 positive with or without CD22 positive Large B-cell lymphoma;
* relapsed or refractory disease;
* ECOG-PS score=0-2;
* Having at least one measurable lesion;
* 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;
* With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
* Participate in other clinical research in the past 4 weeks;
* 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 overall response rate (ORR) as of 3 months post-CAR-T cells infusion — 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
Trial sites (1)
Facility
City
Region
Status
Beijing Tongren Hospital, Capital Medical University
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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