RecruitingPhase 1NCT06221553

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

Safety and Efficacy of Intraventricular Infusion of B7H3 With IL-7 Receptor Alpha Signaling Chimeric Antigen Receptor T Cell in Diffuse Intrinsic Pontine Glioma


Sponsor

Chulalongkorn University

Enrollment

9 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 1 YearMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new type of CAR-T cell therapy that targets two proteins (B7H3 and IL-7Ra) found on a deadly childhood brain tumor called diffuse intrinsic pontine glioma (DIPG). The engineered immune cells are delivered directly into the brain through a special reservoir device (like an Ommaya catheter). This is a safety and effectiveness trial for children who have already completed standard radiation therapy. **You may be eligible if...** - Your child has been diagnosed with DIPG at any time point after completing standard radiation therapy - Your child is aged 1–18 - Your child already has a brain reservoir catheter (such as Ommaya or Rickham) in place for treatment delivery - Your child's performance score is 60 or above (Lansky or Karnofsky) - Your child's expected survival is at least 8 weeks - Organ function (liver, kidneys, and oxygen levels) meets minimum thresholds **You may NOT be eligible if...** - Your child has a severe heart problem or significant cardiac arrhythmia - Your child has a primary immune deficiency or bone marrow failure syndrome - There is radiographic evidence of impending brain herniation - Your child has another active cancer (beyond DIPG) - Your child has grade 3 or higher difficulty swallowing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALB7H3 specific CAR T cell with IL-7Ra signaling domain

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


Locations(1)

King Chulalongkorn Memorial Hospital

Bangkok, Pathumwan, Thailand

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NCT06221553


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