Cell Therapy for CD7 Positive Acute Leukemia or Mixed Lineage Leukemia Except Those Who Are Diagnosed With T-ALL/T-LBL Using CD7-Specific CAR-T Cells

CD7+ mixed lineage leukemia

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

2021-05-10

2023-05-31

2023-10-30

Completed

50

Inclusion Criteria: 1. 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; 2. CD7+ expression on tumor cells (CD7 positive blasts ≥50% by flow cytometry); 3. Life expectancy greater than 12 weeks; 4. KPS or Lansky score≥60; 5. HGB≥70g/L (can be transfused); 6. oxygen saturation of blood\>90%; 7. Total bilirubin (TBil)≤3 × upper limit normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal; 8. Informed consent explained to, understood by and signed by patient/guardian Exclusion Criteria: 1. 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); 2. Has an active GvHD; 3. Has a history of severe pulmonary function damaging; 4. With other tumors which is/are in advanced malignant and has/have systemic metastasis; 5. Severe or persistent infection that cannot be effectively controlled； 6. Merging severe autoimmune diseases or immunodeficiency disease; 7. Patients with active hepatitis B or hepatitis C(\[HBVDNA+\]or \[HCVRNA+\]); 8. Patients with HIV infection or syphilis infection; 9. Has a history of serious allergies on Biological products (including antibiotics); 10. Clinically significant viral infection or uncontrolled viral reactivation of EBV(Epstein-Barr virus), CMV(cytomegalovirus), ADV(adenovirus), BK-virus, or HHV(human herpesvirus)-6; 11. Presence of symptomatic disorders of the central nervous system, which include but not limited to uncontrolled epilepsy, cerebrovascular ischemia/hemorrhage, dementia, and cerebellar disease, etc.; 12. Have received transplant treatment for less than 6 months in prior to enrollment; 13. Being pregnant and lactating or having pregnancy within 12 months; 14. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}

2024-06-14