NGS-MRD Assessment of Combination Immunotherapies Targeting B-ALL

Summary

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.

Eligibility

Inclusion Criteria:

1. Age older than 6 months.
2. High-burden (≥30% blast cells) B-ALL tumor specimen for clonal IgH identification and CTL/DC vac preparation is required
3. Expression of CD19, CD22, CD20, CD10 or CD123 is determined in malignant cells by flow cytometry or immuno-histochemical staining.
4. Karnofsky performance status (KPS) score is higher than 60 and life expectancy \> 3 months.
5. 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.
6. No cell separation contraindications.
7. Abilities to understand and the willingness to provide written informed consent.

Exclusion Criteria:

1. Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection.
2. Active bacterial, fungal or viral infection not controlled by adequate treatment.
3. Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
4. Pregnant or nursing women may not participate.
5. History of glucocorticoid for systemic therapy within the week prior to entering the test.
6. Previously treatment with any gene therapy products.
7. Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.

Conditions2

Interventions1

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