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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Antigen-specific T cells CART/CTL and DCvac
Biological/VaccineAntigen-specific T cells CAR-T/CTL and DCvac cells to treat B-ALL
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: CART/CTL/DCvac cells to treat B-ALLExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety of infusion
Treatment-related adverse events are assessed by NCI CTCAE V4.0 criteria and physiological parameters (for safety, measuring cytokine response, fever, symptoms)
Time frame
1 year2
Clinical response
Leukemia blast cells are detected by multiparameter flow cytometry, and MRD is measured by IgH NGS.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov