Clinical trial · Interventional
NGS-MRD Assessment of Combination Immunotherapies Targeting B-ALL
NGS-MRD Evaluation of Antigen-specific T Cells and DC Vaccine Combination Targeting B-cell Acute Lymphoblastic Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-Cell Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Antigen-specific T cells CART/CTL and DCvac | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CART/CTL/DCvac cells to treat B-ALL
- interventionNames
- Biological: Antigen-specific T cells CART/CTL and DCvac
Primary outcomes (2)
- measure
- Safety of infusion
- timeFrame
- 1 year
- description
- Treatment-related adverse events are assessed by NCI CTCAE V4.0 criteria and physiological parameters (for safety, measuring cytokine response, fever, symptoms)
- measure
- Clinical response
- timeFrame
- 1 year
- description
- Leukemia blast cells are detected by multiparameter flow cytometry, and MRD is measured by IgH NGS.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available