Safety and Efficacy of Loco-regional B7H3 IL-7Ra CAR T Cell in DIPG

ConditionsDIPG Brain Tumor Diffuse Intrinsic Pontine Glioma

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age1-18

SponsorChulalongkorn University

About this trial

A Phase 1 clinical trial to evaluate the safety and early efficacy of CAR T-cell with IL-7Ra signal targeting B7H3 in children with diffuse intrinsic pontine glioma (DIPG) patients after complete standard treatments.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have diffuse intrinsic pontine glioma at any timepoint following completion of standard radiotherapy

Age 1-18 years

Sex: Male or female

CNS reservoir catheter, such as an Ommaya or Rickham catheter, present in the proper location for CNS-directed therapy

Disqualifiers

Presence of >= grade 3 cardiac dysfunction or symptomatic arrythmia requiring intervention

Presence of primary immunodeficiency or bone marrow failure syndrome

Presence of clinical and/or radiographic evidence of impending herniation of CNS

Presence of > Grade 3 dysphagia

Trial design

Design model

Single group

Treatments tested in this trial

B7H3 specific CAR T cell with IL-7Ra signaling domain
Biological/Vaccine
Autologous T cells lentivirally transduced to express a B7H3 specific chimeric antigen receptor (CAR) with additional of IL-7 receptor alpha signalingdomain given via indwelling central nervous system (CNS) catheter

Treatment groups

9 Participants

are divided into 1 treatment group

Group A: Locoregional delivery of B7H3/IL-7Ra CAR T cell in DIPGExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Safety of B7H3-IL7Ra CAR T cells infusion in diffuse intrinsic pontine glioma (DIPE) patients.

The incidence of adverse events assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0

Time frame

Up to 28 days after B7H3-IL7Ra CAR-T cell infusion

Secondary outcomes

The overall response rate of diffuse intrinsic pontine glioma (DIPE)

The overall response rate will be assessed using radiologic response criteria that use the standard sum of the two longest 2D perpendicular diameters to distinguish stable disease, progressive disease (\>25% increase), partial response (\>50% decrease), and complete response (no evaluable or measurable disease).

Time frame

3, 6, and 12 months after B7H3-IL7Ra CAR-T cell infusion

Other outcomes

The persistence and distribution of B7H3-IL7Ra CAR T cells in the CSF and peripheral blood

The persistence and distribution of B7H3-IL7Ra CAR T cells in the CSF and peripheral blood of diffuse intrinsic pontine glioma patients will be measured by flow cytometry.

Time frame

14 days, 28 days, 42 days 3 months, 6 months, and 12 months after B7H3-IL7Ra CAR-T cell infusion

Serum cytokine level measurement

Serum cytokine level measurement before and after B7-H3-IL7Ra CAR T-cell infusion.

Time frame

1 day, 14 days, 28 days and 42 days after B7H3-IL7Ra CAR-T cell infusion.