CD7 CAR-T Bridging to alloHSCT for R/R CD7+Malignant Hematologic Diseases
Hematologic Diseases, Neoplasms
About this trial
This is an interventional treatment trial for Hematologic Diseases focused on measuring allo-HSCT, CD7 CAR-T
Eligibility Criteria
Inclusion Criteria: Provision of signed and dated informed consent form (ICF) Male or female, 18-75 years old Anticipated survival time more than 12 weeks Eastern Cooperative Oncology Group (ECOG) performance status ≤2 According to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphocytic Leukemia and Acute Myeloid Leukemia (2016. v1), patients diagnosed as CD7+ALL and AML Consistent with r/r CD7+acute leukemia diagnosis, including any of the following conditions a. No CR after standard chemotherapy b. The first induction reaches CR, but CR ≤ 12 months c. Patients with r/r CD7+acute leukemia have not responded to the first or multiple remedial treatments d. Multiple recurrences Philadelphia chromosome negative (Ph -) subjects; Or cannot tolerate tyrosine kinase inhibitor (TKI) treatment; Or Philadelphia chromosome positive (Ph+) subjects who did not respond to both TKI treatments Normal lung function, oxygen saturation greater than 92% without oxygen inhalation The blood biochemical test results are consistent with the following results a. (AST) and (ALT) ≤ 2.5 × (ULN) b. Total bilirubin ≤ 1.5 × ULN c. 24-hour serum creatinine clearance ≥ 30 mL/min d. Lipase and amylase ≤ 2 × ULN Fertility capable men and women of childbearing age must agree to use effective contraception starting with the signing of an informed consent form until within 2 years after the use of the study drug. Women of reproductive age include pre menopausal women and women within 2 years after menopause. The blood pregnancy test for women of reproductive age must be negative at screening Exclusion Criteria: Patients with the history of epilepsy or other CNS disease Pregnant or breastfeeding Active infection with no cure Patients with prolonged QT interval time or severe heart disease Have experienced hypersensitivity or intolerance to any drug used in this study Patients who received anticancer chemotherapy or other drug treatment within 2 weeks before screening Previous malignant tumors that require treatment or have evidence of recurrence within the previous 5 years of screening Clinically significant central nervous system lesions such as seizures, cerebral vascular ischemia/hemorrhage, dementia, cerebellar disease, psychosis, active central nervous system involvement, or cancerous meningitis In the past 2 years, terminal organ damage caused by autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) or the need for systematic application of immunosuppressive or other systemic disease control drugs Severe active viral, bacterial, or uncontrolled systemic fungal infections; Genetic bleeding/coagulation disorders, a history of non-traumatic bleeding or thromboembolism, and other diseases that may increase the risk of bleeding Patients who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks before screening, or who plan to undergo ASCT during this study Participated in clinical trials of other drugs within 4 weeks or 5 drug half-lives (T1/2) before screening Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
Sites / Locations
- The first affiliated hospital of medical college of zhejiang universityRecruiting
Arms of the Study
Arm 1
Experimental
Treatment Group
R/R CD7+Malignant Hematologic Diseases