Clinical Study of Senl-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ Acute T-AL… (NCT05626400) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Study of Senl-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ Acute T-ALL/T-LBL
China100 participantsStarted 2022-08-29
Plain-language summary
This is an open, prospective, dose-escalation clinical study to evaluate the safety and efficacy of Senl-T7 in patients with relapsed or refractory CD7+ acute T lymphoblastic leukemia or T lymphoblastic lymphoma.Meanwhile, PK/PD indexes of Senl-T7 were collected.
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%#;
✓. HGB≥70g/L（blood transfusion allowed）;
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;
✕. Has a history of severe pulmonary function damaging;
What they're measuring
1
Safety: Incidence and severity of adverse events
Timeframe: First 1 month post CAR-T cells infusion