NGS-MRD Assessment of Combination Immunotherapies Targeting B-ALL
Recruiting now · Phase 1
Conditions studied: B-Cell Acute Lymphoblastic Leukemia
In brief
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.
Key facts
- Study ID
- NCT05262673
- Run by
- Shenzhen Geno-Immune Medical Institute
- People needed
- 10
- Starts
- 2026-06-01
- Expected to finish
- 2030-12-31
- Last updated by the study team
- 2026-06-23
Who can join
Age: 1 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
- Pregnant or nursing women may not participate.
- History of glucocorticoid for systemic therapy within the week prior to entering the test.
- Previously treatment with any gene therapy products.
- Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.
Where it is running
- Shenzhen Geno-Immune Medical Institute — Shenzhen, Guangdong, China (enrolling)
Full record on ClinicalTrials.gov
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