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Study of Anti-CD22 CAR-T Cells Treating Leukemia Children
Bu Faz 2 (Phase 2) çalışma, dirençli veya nüksetmiş B hücreli akut lenfoblastik lösemisi (relapsed or refractory B-cell acute lymphoblastic leukemia, B-ALL) olan çocuklarda, hastanın kendi hücrelerinden üretilen insanlaştırılmış (humanized) anti-CD22 kimerik antijen reseptörlü T hücrelerini (chimeric antigen receptor T cells, CAR-T) inceliyor. Katılımcıların yoğun tedavi görmüş olması, nüks sonrası yeniden indüksiyon kemoterapisine yanıt vermemiş olması ya da üç aydan uzun süre minimal kalıntı hastalık (minimal residual disease, MRD) pozitifliği göstermesi ve lösemi hücrelerinde akım sitometrisi (flow cytometry) ile CD22 ifadesi saptanmış olması gerekiyor. CAR T hücre infüzyonundan sonra genel sağkalım (overall survival), hastalıksız sağkalım (disease-free survival), yan etkiler ve nüks değerlendiriliyor.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
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).