NGS-MRD Evaluation of Antigen-specific T Cells and DC Vaccine Combination Targeting B-cell Acute Lymphoblastic Leukemia
The purpose of this study is to determine the feasibility, safety, and efficacy of a combination therapy in the treatment of B-cell acute lymphoblastic leukemia (B-ALL) based on multi-antigen-targeted chimeric antigen receptor T cells (CAR-T) followed by engineered immune effector cytotoxic T lymphocytes (CTLs) and immune-modified dendritic cell vaccine (DCvac). This approach is aimed to achieve NGS MRD negative in B-ALL patients, which can identify a very low risk of relapse and define patients with possible long-term remission without further treatment.
• Age older than 6 months.
• High-burden (≥30% blast cells) B-ALL tumor specimen for clonal IgH identification and CTL/DC vac preparation is required
• Expression of CD19, CD22, CD20, CD10 or CD123 is determined in malignant cells by flow cytometry or immuno-histochemical staining.
• Karnofsky performance status (KPS) score is higher than 60 and life expectancy \> 3 months.
• Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5x upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3x upper limit of normal, total bilirubin ≤ 2.0mg/dL.
• No cell separation contraindications.
• Abilities to understand and the willingness to provide written informed consent.