Diffuse Intrinsic Pontine GliomaPhase 2NCT07680439
Illuminate: A Clinical Study Evaluating CAR T Immune Cell Therapy (BCB-276) for Patients With Diffuse Intrinsic Pontine Glioma (DIPG).
A Phase 2 study testing BCB-276 in people with Diffuse Intrinsic Pontine Glioma and DIPG, run by BrainChild Bio, Inc at 6 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 26 years
- Conditions the study is for
- Diffuse Intrinsic Pontine Glioma, DIPG, Brain Tumor
- What is being tested?
- BCB-276
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 6 sitesUnited States
- Study dates
- 4 Sep 2026to Jul 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Not yet recruiting
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
aflacdevtreferral@choa.org
Sheila McThenia, MD
- Not yet recruiting
Lurie Children's Hospital
Chicago, Illinois, 60611
Alicia Lenzen, MD, 312-227-4090, alenzen@luriechildrens.org
Arinchaya Limpanich, CRC, alimpanich@luriechildrens.org
- Not yet recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Ryuma Tanaka, MD, 614-722-3250, Ryuma.Tanaka@nationwidechildrens.org
Joanna Weinbrecht-Acree, 614-355-1232, Joanna.Weinbrecht-Acree@nationwidechildrens.org
- Not yet recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
323-361-2121, neurooncresearch@chla.usc.edu
Tom Davidson, MD
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
CART Nurse Navigator, 445-942-5981, CARTNurseNavigator@chop.edu
Jessica Foster, MD
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
HemOnc Clinic, 206-987-2106, HemOncCRAs@seattlechildrens.org
Sarah Leary, MD
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Diffuse Intrinsic Pontine Glioma, DIPG, Brain Tumor, CNS Tumor, Central Nervous System Tumor, Pediatric Cancer
- Being tested
- BCB-276
- Keywords
- BCB-276, B7-H3-specific Chimeric Antigen Receptor [CAR] T cell therapy, B7-H3, B7-H3 CAR T, B7-H3 CAR T Cells, Chimeric antigen receptor T cells, CAR T Cell, Immunotherapy, Cell Therapy, Pediatric, Children, Adolescent, Young Adult, Adult
- Medical subject headings
- Diffuse Intrinsic Pontine Glioma, Brain Neoplasms, Central Nervous System Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCB-276Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| BCB-276 CAR-T therapy for newly diagnosed DIPG patients post-radiation therapy | Experimental | 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. Receives: Biological: BCB-276 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Up to 24 months from date of enrollment
Measured: 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).
Secondary outcomes (4)
Safety and Tolerability of BCB-276
Incidence of adverse events, including serious adverse events, and adverse events leading to discontinuation of study treatment.
Measured: Up to 35 weeks from enrollment (28 days after last dose of BCB-276).
Radiographic Response to BCB-276
Measure the frequency of disease response (progressive disease, stable disease, partial response, complete response) based on MRI assessment per RANO criteria.
Measured: Up to 24 months from date of enrollment.
Presence of BCB-276 in Cerebrospinal Fluid (CSF)
Quantify the presence and amount of BCB-276 in CSF.
Measured: Up to approximately 30 weeks from first dose of BCB-276.
Progression-Free Survival (PFS)
PFS as measured by time in months, from date of diagnosis to first incidence of clinical or radiographically confirmed progression.
Measured: Up to approximately 24 months from date of enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start4 Sep 2026
- Primary completionOct 2028 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Intrinsic Pontine GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, externally controlled phase 2 clinical study. All eligible participants will receive BCB-276 by repeated intraventricular administrations for a planned course of up to 15 doses. The primary endpoint for the study is overall survival which will be compared to outcomes from a registry of similar individuals with DIPG treated with standard therapy. The starting point for outcome measurement will be aligned between study participants and registry patients. All enrolled participants will be considered evaluable for the primary endpoint regardless of whether they received BCB-276.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BrainChild Bio, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cori Abikoff, MD, Study director, BrainChild Bio, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680439
- Sponsor's protocol ID
- BCB276-PRT-0001
- Status last verified
- Oct 2026
- First submitted
- 22 Jun 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Pivotal Study of BCB-276, a B7-H3-Specific CAR T Cell Locoregional Immunotherapy for Diffuse Intrinsic Pontine Glioma
- ClinicalTrials.gov ID
- NCT07680439
- Acronym / sponsor ID
- BCB276-PRT-0001
- Conditions
- Diffuse Intrinsic Pontine Glioma, DIPG, Brain Tumor, CNS Tumor, Central Nervous System Tumor, Pediatric Cancer
- Keywords
- BCB-276, B7-H3-specific Chimeric Antigen Receptor [CAR] T cell therapy, B7-H3, B7-H3 CAR T, B7-H3 CAR T Cells, Chimeric antigen receptor T cells, CAR T Cell, Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- BrainChild Bio, IncIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2026 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, externally controlled phase 2 clinical study. All eligible participants will receive BCB-276 by repeated intraventricular administrations for a planned course of up to 15 doses. The primary endpoint for the study is overall survival which will be compared to outcomes from a registry of similar individuals with DIPG treated with standard therapy. The starting point for outcome measurement will be aligned between study participants and registry patients. All enrolled participants will be considered evaluable for the primary endpoint regardless of whether they received BCB-276.
| Arm | Type | Receives |
|---|---|---|
| BCB-276 CAR-T therapy for newly diagnosed DIPG patients post-radiation therapy | Experimental | Biological: BCB-276Participants will receive up to 15 intraventricular administrations of BCB-276 delivered every 14 days (+/- 2 days) for an approximate total duration of 30 weeks. |
Who may qualify
- Ages
- 1 year to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCB-276Following 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. | Biological | BCB-276 CAR-T therapy for newly diagnosed DIPG patients post-radiation therapy |
Primary outcome
Overall Survival
Time frame: 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
4 secondary outcomes
Safety and Tolerability of BCB-276
Time frame: Up to 35 weeks from enrollment (28 days after last dose of BCB-276).
Radiographic Response to BCB-276
Time frame: Up to 24 months from date of enrollment.
Presence of BCB-276 in Cerebrospinal Fluid (CSF)
Time frame: Up to approximately 30 weeks from first dose of BCB-276.
Progression-Free Survival (PFS)
Time frame: Up to approximately 24 months from date of enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cori Abikoff, MD study director
BrainChild Bio, Inc
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BCB-276 in people with Diffuse Intrinsic Pontine Glioma and DIPG, run by BrainChild Bio, Inc at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BrainChild Bio Study Team (425-569-8747, clinicaltrials@brainchildbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.