NCT05277753TerminatedPhase 1
NGS-MRD Assessment of Combination Immunotherapies Targeting T-ALL
NGS-MRD Evaluation of Antigen-specific T Cells and DC Vaccine Combination Targeting T-cell Acute Lymphoblastic Leukemia
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
The purpose of this study is to determine the feasibility, safety, and efficacy of a combination therapy in the treatment of T-cell acute lymphoblastic leukemia (T-ALL): multi-antigen-targeted chimeric antigen receptor T cells (CAR-T) followed by engineered immune effector cytotoxic T cells (CTLs) and immune modified dendritic cell vaccine (DCvac). This approach is aimed to achieve NGS MRD negativity in T-ALL patients, which can identify a very low risk of relapse and define patients with possible long-term remission without further treatment.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 21 Feb 2022
- Start date
- 1 Jun 2026
- Primary completion date
- 1 Jul 2026
- Lead sponsor
- Shenzhen Geno-Immune Medical Institute
- NCT number
- NCT05277753
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of glucocorticoid for systemic therapy within the week prior to entering the test.
- Previous treatment with any gene therapy products.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 6 months to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shenzhen Geno-immune Medical Institute | Shenzhen | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.