CD19 CAR-T Cell Therapy in Adults With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia: A Phase I/II Study

Prior treatment

• Recipient of CAR-T cell therapy outside this protocol
• Active involvement of the central nervous system or meninges by any neoplasm (patients with a history of CNS or meningeal involvement must be in documented remission by CSF evaluation for at least 90 days before registration)

Other illness

• History of active malignant neoplasm other than the underlying B-cell ALL, excluding non-melanoma skin cancer
• Active or ongoing infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, pulmonary abnormalities, or psychiatric illnesses/social situations that would limit compliance with the study requirements
• Active infection by human immunodeficiency virus (HIV)
• Serologic status that reflects active infection by hepatitis B or C
• History of COVID-19 infection in the last 3 months

Other

• Pregnant or breastfeeding women
• Evidence of myelodysplasia in bone marrow aspirate before the start of treatment
• Grade 1 or higher adverse events associated with SARS-CoV-2, with the exception of peripheral neuropathy

• From 18 to 60 years old
• Signed informed consent prior to participation in the study
• Diagnosis of relapsed or refractory B-cell ALL after at least two lines of treatment
• Documented CD19 positivity either by immunohistochemistry analysis or flow cytometry in the last available evaluation
• ECOG performance status ≤2
• Women of childbearing potential must have a negative serum pregnancy test
• Adequate renal, hepatic, pulmonary, and cardiac function
• Bone marrow function specifications at least 48 hours prior to recruitment: hemoglobin ≥8 g/dL, absolute neutrophil count (ANC) ≥500/µL, absolute lymphocyte count ≥300/µL, platelet count ≥30,000/µL