本研究旨在探討在復發性或難治性急性淋巴細胞白血病（ALL）或淋巴瘤兒童中，於化療淋巴清除方案後，給予經導入靶向B細胞表面抗原CD19的嵌合抗原受體（CAR）修飾的自體T細胞之療效與安全性。

適應症：Lymphoma, B-Cell、Acute Lymphoblastic Leukemia, Pediatric

收案條件

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.

收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。

CD-19 CAR-T細胞用於兒童ALL或淋巴瘤