NGS-MRD Assessment of Combination Immunotherapies Targeting B-ALL
ConditionB-Cell Acute Lymphoblastic Leukemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age6-65
SponsorShenzhen Geno-Immune Medical Institute
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Antigen-specific T cells CART/CTL and DCvac
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov