Clinical Study of SenL-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ T-cell Lym… (NCT04916860) | Clinical Trial Compass
UnknownNot Applicable
Clinical Study of SenL-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
China100 participantsStarted 2021-01-27
Plain-language summary
This is an open, single-arm, clinical study to evaluate efficacy and safety of anti CD7 CAR-T cell in the treatment of relapsed and refractory CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma
Who can participate
Age range2 Years – 70 Years
SexALL
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Inclusion criteria
✓. Diagnosis of relapsed/refractory T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma: Induction therapy failed to achieve a complete remission of minor residual negative; Recurrence: after complete remission, any tumor load in the peripheral blood or bone marrow was 5%, or slightly residual positive, or new extramedullary lesions occurred；
✓. CD7 expression in tumor cells was detected by flow cytometry；
✓. Life expectancy greater than 12 weeks；
✓. KPS or Lansky score≥60;
✓. HGB≥70g/L (can be transfused);
✓. 2-70 years old;
✓. oxygen saturation of blood#90%#;
✓. Total bilirubin (TBil)≤3 × upper limit normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal;
Exclusion criteria
✕. Any of the following cardiac criteria: Atrial fibrillation/flutter; Myocardial infarction within the last 12 months; Prolonged QT syndrome or secondary prolonged QT, per investigator discretion. Cardiac echocardiography with LVSF (left ventricular shortening fraction)\<30% or LVEF(left ventricular ejection fraction)\<50%; or clinically significant pericardial effusion. Cardiac dysfunction NYHA(New York Heart Association) III or IV (Confirmation of absence of these conditions on echocardiogram within 12 months of treatment);
✕. Has an active GvHD;
✕
What they're measuring
1
Safety: Incidence and severity of adverse events
Timeframe: First 1 month post CAR-T cells infusion