75 Participants NeededMy employer runs this trial

CAR T Cell Therapy for Brain Cancer

Recruiting at 5 trial locations
BB
Overseen ByBrainChild Bio Study Team
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BCB-276, a type of CAR T cell therapy, designed to help children and young adults with diffuse intrinsic pontine glioma (DIPG), a rare and aggressive brain tumor. The treatment modifies a patient's own immune cells in a lab to target and destroy cancer cells and is administered after standard radiation therapy to assess its safety and potential to extend survival. Participants must have a DIPG diagnosis, have completed radiation therapy within the last six weeks, and not have received treatments beyond radiation. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to potential advancements in DIPG therapy.

Is there any evidence suggesting that BCB-276 CAR T cell therapy is likely to be safe for humans?

Research has shown that BCB-276 CAR T-cell therapy can cause common side effects, such as headaches, tiredness, and fever. In other studies with patients who received BCB-276, the average survival time after starting the therapy was 10.7 months, suggesting that the treatment might extend the lives of patients with brain tumors like DIPG.

The FDA has granted BCB-276 breakthrough therapy status, indicating its promise in early tests. These studies help researchers understand how well patients tolerate the treatment and identify potential side effects. Overall, BCB-276 appears to be generally well-tolerated, with manageable side effects.12345

Why do researchers think this study treatment might be promising for brain cancer?

Most treatments for brain cancer, like chemotherapy and radiation, work by attacking cancer cells broadly, which can also harm healthy cells. But BCB-276 CAR T therapy is different because it uses genetically modified immune cells, called CAR T cells, to specifically target and attack cancer cells in the brain. This precision reduces damage to healthy tissue and holds promise for more effective results. Additionally, BCB-276 is administered directly into the brain's ventricular system, which could enhance its ability to reach and penetrate cancerous areas that are difficult for traditional treatments to access. Researchers are excited because this novel approach may offer a more targeted and potentially safer treatment option for patients with difficult-to-treat brain cancers like DIPG.

What evidence suggests that BCB-276 might be an effective treatment for DIPG?

Research has shown that BCB-276 CAR T cell therapy could be promising for treating diffuse intrinsic pontine glioma (DIPG), a challenging brain tumor. In studies, patients who received BCB-276 lived an average of 10.7 months after the therapy and 19.8 months from diagnosis. This surpasses the usual survival time of about 11 months for DIPG patients. In this trial, participants will receive BCB-276 CAR-T therapy following radiation therapy. BCB-276 uses the body's own immune cells, modified to locate and attack cancer cells. These early results suggest that BCB-276 might extend the lives of people with DIPG.23456

Who Is on the Research Team?

CA

Cori Abikoff, MD

Principal Investigator

BrainChild Bio, Inc

Are You a Good Fit for This Trial?

This trial is for children and young adults (ages 1–26) diagnosed with diffuse intrinsic pontine glioma (DIPG). Participants must join within 6 weeks after finishing their first radiation therapy and cannot have had other cancer treatments besides radiation, with or without temozolomide.

Inclusion Criteria

I am between 1 and 26 years old and weigh at least 10 kg.
Central Nervous System (CNS) reservoir catheter present prior to first dose of study drug
Participant must meet all other health and safety criteria defined in the study protocol
See 8 more

Exclusion Criteria

I have had previous cancer treatments or joined a treatment study, except standard radiation or temozolomide.
Pregnant or breastfeeding
Severe swallowing difficulties or other significant clinical conditions that may interfere with participation
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to 15 intraventricular administrations of BCB-276 every 2 weeks over approximately 7-8 months

30 weeks
15 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including MRI scans and laboratory tests

24 months
Some visits may be conducted remotely

What Are the Treatments Tested in This Trial?

Interventions

  • BCB-276

Trial Overview

The study tests BCB-276, a CAR T cell therapy designed to target brain tumors. The treatment uses the patient’s own immune cells, modified in a lab, given through a catheter into the fluid around the brain every two weeks for several months after standard radiation.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: BCB-276 CAR-T therapy for newly diagnosed DIPG patients post-radiation therapyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

BrainChild Bio, Inc

Lead Sponsor

Citations

FDA Awards RMAT Designation to BCB-276 CAR T-Cell ...

among evaluable patients with DIPG the median overall survival was 10.7 months after BCB-276 infusion and 19.8 months after diagnosis. 3 ...

Intracerebroventricular B7-H3-targeting CAR T cells for ...

Diffuse intrinsic pontine glioma (DIPG) is a fatal central nervous system (CNS) tumor that confers a median survival of 11 months.

Breakthrough Designation Granted to BCB-276 for ...

data demonstrated that evaluable patients with DIPG (n = 21) experienced a median overall survival (OS) of 10.7 months following the infusion ...

A Clinical Study Evaluating CAR T Immune Cell Therapy ...

This study will evaluate BCB-276, an investigational B7-H3-targeted Chimeric Antigen Receptor (CAR) T cell therapy, in children and young ...

BrainChild Bio's Pediatric Brain Tumor CAR-T BCB-276 ...

The FDA's decision was supported by data indicating overall survival benefit for patients with brain tumors from the phase 1 BrainChild-03 ...

Novel CAR T Therapy Earns FDA Breakthrough Status for ...

FDA designates BCB-276 as a breakthrough therapy for pediatric DIPG, offering hope for improved treatment of this challenging brain tumor.