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This Phase 2 study examines autologous humanized anti-CD22 chimeric antigen receptor (CAR) T cells in children with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL). Eligible participants are heavily treated patients who failed re-induction chemotherapy after relapse or had persistent minimal residual disease (MRD) for more than three months, with CD22 expression on leukemia cells by flow cytometry. After CAR T-cell infusion, overall survival, disease-free survival, adverse effects and relapse are evaluated.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Patients who were diagnosed as primary refractory or relapsed B-ALL. All the patients matched the diagnostic criteria of ALL according to the WHO classification and conducted morphological evaluation, immunophenotype analysis by flow cytometry (FCM), cytogenetic analysis by routine G-banding karyotype analysis, screen of 56 leukemia-related fusion genes by multiplex nested reverse transcriptase-polymerase chain reaction (RT-PCR), and quantification of fusion genes by real-time PCR with ABL1 as reference. * Extramedullary diseases (EMDs) were confirmed CD22+ by FCM and evaluated by positron emission tomography/computed tomography (PET/CT), CT, MRI or ultrasonography. * The patient relapsed during chemotherapy or failed from re-induction chemotherapy (including first and second-generation TKIs) after relapse or had a persistent positive minimal residual disease (MRD) for three months. Patients had positive CD22 expression on leukemia blasts by FCM (\>95% CD22 positive); * Age from 0 to 18 years old; * Children candidates can be recruited after the legal guardian or patient advocate has signed the treatment consent form and voluntary consent form. Exclusion Criteria: * Intracranial hypertension or unconscious; * Acute heart failure or severe arrhythmia; * Acute respiratory failure; * Other types of malignant tumors; * Diffuse intravascular coagulation; * Serum creatinine and/or blood urea nitrogen over 1.5 times than normal range; * Sepsis or other uncontrolled infection; * Uncontrolled diabetes mellitus; * Severe psychological disorder; * Obvious cranial lesions with cranial MRI; * More than 20 counts/ul leukemic cells in cerebrospinal fluid; * More than 30% leukemic cells in the blood; * Stage III WHO/ECOG score; * Organ recipients; * Pregnant or breastfeeding; * Active, uncontrolled infection, including hepatitis B, hepatitis C or human immunodeficiency virus (HIV).