Cell Therapy for CD7 Positive Acute Myeloid Leukemia or Mixed Lineage Leukemia (NCT04938115) | Clinical Trial Compass
CompletedNot Applicable
Cell Therapy for CD7 Positive Acute Myeloid Leukemia or Mixed Lineage Leukemia
China50 participantsStarted 2021-05-10
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 CD7 Positive acute leukemia or mixed lineage leukemia except those who are diagnosed with T-ALL/T-LBL
Who can participate
Age range2 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Diagnosis of refractory or relapsed CD7+ acute myeloid leukemia or mixed lineage leukemia was made according to the NCCN 2019.V2 guideline. Refractory AML is defined as a patient who has failed to achieve complete remission after induction therapy. Relapsed AML is defined as the reappearance of blasts (5%) in either peripheral blood or bone marrow. Patient diagnosed with AML should be treated and whose disease failed with at least 2 prior lines of therapies. Patients whose tumor burden ≥5% blasts, or who have persistent positive minimal residual disease (MRD), or have reappearance of extramedullary lesions are also considered eligible;
✓. CD7+ expression on tumor cells (CD7 positive blasts ≥50% by flow cytometry);
✓. Life expectancy greater than 12 weeks;
✓. KPS or Lansky score≥60;
✓. HGB≥70g/L (can be transfused);
✓. oxygen saturation of blood\>90%;
✓. Total bilirubin (TBil)≤3 × upper limit normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal;
✓. Informed consent explained to, understood by and signed by patient/guardian
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);
What they're measuring
1
Safety: Incidence and severity of adverse events
Timeframe: First 1 month post CAR-T cells infusion