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Illuminate: A Clinical Study Evaluating CAR T Immune Cell Therapy (BCB-276) for Patients With Diffuse Intrinsic Pontine Glioma (DIPG).

25. juni 2026 opdateret af: BrainChild Bio, Inc

A Phase 2 Pivotal Study of BCB-276, a B7-H3-Specific CAR T Cell Locoregional Immunotherapy for Diffuse Intrinsic Pontine Glioma

This study will evaluate BCB-276, an investigational B7-H3-targeted Chimeric Antigen Receptor (CAR) T cell therapy, in children and young adults with diffuse intrinsic pontine glioma (DIPG). DIPG is a rare and aggressive brain tumor with limited treatment options. CAR T cell therapy uses a patient's own immune cells that are changed in a laboratory to recognize and attack cancer cells. The purpose of this study is to determine whether BCB-276, when given after completion of standard radiation therapy, is safe and can improve survival for patients with DIPG.

To participate, individuals must be between 1 and 26 years of age when they join the study, have a diagnosis of DIPG, and enroll for treatment within 6 weeks of completing initial radiation therapy. Participants must not have received prior anti-cancer therapy beyond radiation with or without temozolomide prior to joining this study.

BCB-276 is administered intraventricularly (into the fluid around the brain), which requires placement of a catheter for treatment. BCB-276 is given every 2 weeks at a research center over a period of several months (approximately 7-8 months). Participation includes travel to a study site, procedures to support treatment administration, sample collection, and ongoing monitoring for safety and effectiveness, with follow-up visits lasting up to about 2 years.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Diffuse intrinsic pontine glioma (DIPG) is a rare and aggressive brainstem tumor that primarily affects children and has limited treatment options. Radiation therapy is the current standard of care and may provide temporary benefit, but new treatment approaches are needed.

This Phase 2 study will evaluate BCB-276, an investigational B7-H3-targeted Chimeric Antigen Receptor (CAR) T cell therapy, in children and young adults with DIPG after completion of initial standard radiation therapy. The study will assess survival, safety, and tumor response. All eligible participants will receive BCB-276, and outcomes will be compared with information from similar individuals with DIPG whose data have been collected in a registry.

To take part in this study, eligible patients must begin participation within 6 weeks after completing radiation therapy and must not have received prior anti-cancer therapy other than radiation with or without temozolomide. Participation includes collection of participant's white blood cells by leukapheresis, manufacturing of BCB-276 from the participant's own immune cells, and placement of a catheter or reservoir to deliver treatment directly into the fluid-filled spaces of the brain.

BCB-276 is given at participating research centers approximately every 2 weeks for a planned course of up to 15 doses over approximately 7-8 months. Study visits include treatment, safety monitoring, MRI scans, laboratory tests, and other assessments. Participants may be followed for up to approximately 2 years from the first BCB-276 treatment, and some follow-up visits may be conducted remotely. Because BCB-276 is investigational, side effects may occur and safety will be closely monitored.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

75

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90027
        • Children's Hospital Los Angeles
        • Ledende efterforsker:
          • Tom Davidson, MD
        • Kontakt:
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30329
    • Illinois
    • Ohio
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Children's Hospital of Philadelphia
        • Kontakt:
        • Ledende efterforsker:
          • Jessica Foster, MD
    • Washington
      • Seattle, Washington, Forenede Stater, 98105
        • Seattle Children's Hospital
        • Ledende efterforsker:
          • Sarah Leary, MD
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Participants must be aged 1 and ≤ 26 years and weigh ≥10kg.
  • Diagnosis of Diffuse Intrinsic Pontine Glioma (DIPG) based on imaging, with or without biopsy confirmation consistent with high-grade glioma or diffuse midline glioma
  • Able to tolerate leukapheresis and other study procedures in the opinion of the Investigator.
  • Central Nervous System (CNS) reservoir catheter present prior to first dose of study drug.
  • Participant must have completed standard radiation therapy within 6 weeks of enrollment for participation.
  • Performance Status of ≥ 60; mild to moderate restriction or better. Lansky (under 16 years of age) or Karnofsky (16 years of age or older).
  • Adequate organ function and overall clinical status to participate, including stable or improving neurologic symptoms.
  • Participants of childbearing/fathering potential must agree to use highly effective contraception from the time of enrollment through 12 months following the last T cell infusion.
  • Participants with ventriculoperitoneal (VP) shunts need to have a programable system and be able to tolerate temporary adjustment of the shunt required for study treatment.
  • Participant must meet all other health and safety criteria defined in the study protocol.
  • Participant and/or authorized legal representative willing to provide consent/assent for study participation, including participation in the 15-year long term follow up period.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

  • Previous tumor-directed therapy or treatment-directed clinical study other than standard radiation with or without temozolamide.
  • Evidence of metastatic disease.
  • Requirement of high or increasing doses of corticosteroids prior to participation.
  • Severe swallowing difficulties or other significant clinical conditions that may interfere with participation.
  • Presence of an active malignancy other than DIPG.
  • Active or uncontrolled human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection based on protocol-required laboratory testing.
  • Pregnant or breastfeeding.
  • Presence of any condition that, in the Investigator's opinion, would prohibit the participant from undergoing treatment under this protocol.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: BCB-276 CAR-T therapy for newly diagnosed DIPG patients post-radiation therapy
Participants will receive up to 15 intraventricular administrations of BCB-276 delivered every 14 days (+/- 2 days) for an approximate total duration of 30 weeks.
Biologisk: BCB-276

Following completion of standard radiation therapy, eligible participants with DIPG will undergo leukapheresis, a procedure to collect white blood cells used to manufacture BCB-276, an autologous CAR T cell therapy made from the participant's own immune cells designed to target B7-H3.

All eligible participants will receive up to 15 intraventricular administrations of BCB-276 every 2 weeks for an approximate total duration of 30 weeks.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival
Tidsramme: Overall Survival (OS) as defined as time from the date of enrollment to death from any cause (up to 24 months from date of enrollment).
Up to 24 months from date of enrollment
Overall Survival (OS) as defined as time from the date of enrollment to death from any cause (up to 24 months from date of enrollment).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Safety and Tolerability of BCB-276
Tidsramme: Up to 35 weeks from enrollment (28 days after last dose of BCB-276).
Incidence of adverse events, including serious adverse events, and adverse events leading to discontinuation of study treatment.
Up to 35 weeks from enrollment (28 days after last dose of BCB-276).
Radiographic Response to BCB-276
Tidsramme: Up to 24 months from date of enrollment.
Measure the frequency of disease response (progressive disease, stable disease, partial response, complete response) based on MRI assessment per RANO criteria.
Up to 24 months from date of enrollment.
Presence of BCB-276 in Cerebrospinal Fluid (CSF)
Tidsramme: Up to approximately 30 weeks from first dose of BCB-276.
Quantify the presence and amount of BCB-276 in CSF.
Up to approximately 30 weeks from first dose of BCB-276.
Progression-Free Survival (PFS)
Tidsramme: Up to approximately 24 months from date of enrollment.
PFS as measured by time in months, from date of diagnosis to first incidence of clinical or radiographically confirmed progression.
Up to approximately 24 months from date of enrollment.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

BrainChild Bio, Inc

Efterforskere

  • Studieleder: Cori Abikoff, MD, BrainChild Bio, Inc

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. oktober 2028

Studieafslutning (Anslået)

1. juli 2030

Datoer for studieregistrering

Først indsendt

22. juni 2026

Først indsendt, der opfyldte QC-kriterier

25. juni 2026

Først opslået (Faktiske)

2. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BCB276-PRT-0001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Hjerne svulst

Kliniske forsøg med BCB-276

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Betingelser

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Placeringer

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