NGS-MRD Assessment of Combination Immunotherapies Targeting T-ALL

Korábbi kezelés

• History of glucocorticoid for systemic therapy within the week prior to entering the test.
• Previous treatment with any gene therapy products.

Más betegség

• Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection.
• Active bacterial, fungal or viral infection not controlled by adequate treatment.
• Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

Egyéb

• Pregnant or nursing women may not participate.
• Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.

• Age older than 6 months.
• High-burden (≥ 30% blast cells) bone marrow sample for NGS TCR clonal identification and CTL/DC vac preparation is required
• Expression of CD7, CD5, CD317, CD47, CD99, CD38 or TRBC1/2 is determined in malignant cells by flow cytometry or immuno-histochemical staining.
• Karnofsky performance status (KPS) score is higher than 80 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 ≤ 2.0 mg/dL.
• Hgb ≥ 80g/L.
• No cell separation contraindications.
• Abilities to understand and the willingness to provide written informed consent.