The purpose of this clinical trial is to tolerability and safety of humanized CD19 CAR-T therapy with TLR2 in adult patients with acute B lymphoblastic leukemia/lymphoma who cannot tolerate intense chemotherapy at initial treatment. Participants will receive a single infusion of CD19 CAR-T and complete follow-ups over the next three years.
Newly treated patients with acute B-lymphocytic leukaemia/lymphoma who are clinically determined to be unable to tolerate strong chemotherapy;
age 18-80 years old (including boundary value), both men and women can;
The physical status of the American Eastern Cancer Collaboration Group (ECOG) was 0~2 points;
Positive CD19 confirmed by flow cytometry and/or histopathology;
severe cardiac insufficiency, left ventricular ejection fraction <50%;
have a history of severe lung function impairment;
Combined with other advanced malignant tumors;
Had severe infection within 4 weeks before enrollment and could not be effectively controlled;
Single group
humanized CD19 CAR-T Cells with TLR2
Biological/VaccineAdminister a single infusion of humanized CD19 CAR-T Cells with TLR2 to this group of patients following fludarabine plus cyclophosphamide (F+C) lymphodepletion
ORR
Objective response rates (ORR), including CR and PR, were analyzed by Clopper-Pearson distribution with bilateral 95% confidence intervals. For progression-free survival (PFS), Kaplan-Meier method was used to estimate the survival curve. Overall survival: the time from cell retransfusion until death from any cause.
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This trial is not recruiting at the moment. You can still explore other options:
