本研究旨在探讨在复发性或难治性急性淋巴细胞白血病（ALL）或淋巴瘤儿童中，于化疗淋巴清除方案后，给予经导入靶向B细胞表面抗原CD19的嵌合抗原受体（CAR）修饰的自体T细胞之疗效与安全性。

适应症：Lymphoma, B-Cell、Acute Lymphoblastic Leukemia, Pediatric

入组条件

Subjects must have relapsed or refractory ALL or lymphoma treated with at least two lines of therapy. Disease must have either progressed after the last regimen or presented failure to achieve partial or complete remission with the last regimen.
The patient's disease must be CD19 positive, either by immunohistochemistry or flow cytometry analysis on the last biopsy available.
Age 1-17 years.
Performance status: Subjects \> 10 years of age: Karnofsky ≥ 50%; Subjects ≤ 10 years of age: Lansky scale ≥ 50%.
Normal organ function.
Total bilirubin ≤ 3 times upper limit of normal
AST (SGOT) ≤ 5 times upper limit of normal
ALT (SGPT) ≤ 5 times upper limit of normal
Serum Creatinine ≤ 2 times upper limit of normal
Subjects must have the following hematologic function parameters: Hemoglobin (Hb) level \> 8 g/dL; Absolute Lymphocyte Count \> 0.1x10\^9/L; Platelet \> 50x10\^9/L
Prior therapy wash-out. At least 2 weeks or 5 half lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis.
Subjects' parent or legal guardian must have the ability to understand and the willingness to sign a written informed consent document.

Autologous transplant within 6 weeks of planned CAR T cell infusion.
Recipient of CAR-T cell therapy outside of this protocol.
Active central nervous system (CNS) or meningeal involvement by tumor.
History of additional active malignancy other than non-melanoma skin cancer, carcinoma in situ (e.g. cervix, bladder, breast).
Active human immunodeficiency virus (HIV) infection.
Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant or breastfeeding women.
Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy.
Serologic status reflecting active hepatitis B or C infection.

入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。

CD-19 CAR-T细胞用于儿童ALL或淋巴瘤