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NGS-MRD Assessment of Combination Immunotherapies Targeting T-ALL

ConditionT-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 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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 CAR-T/CTL and DCvac

    Biological/Vaccine

    Antigen-specific T cells CAR-T/CTL and DCvac cells to treat T-ALL

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: CART/CTL/DCvac cells to treat T-ALLExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Treatment-related adverse events are assessed by NCI CTCAE V4.0 criteria.

Safety of infusion

Time frame
1 year
2

Clinical response

Leukemia blast cells are detected by multiparameter flow cytometry

Time frame
1 year
3

Evaluate the percentage of minimal leukemia residue in bone marrow

Minimal leukemia residue（MRD）is measured by TCR next generation sequencing（NGS）.

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shenzhen Geno-Immune Medical Institute

Lead sponsor

Source ClinicalTrials.gov
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