Locoregional immunotherapy using CAR T cells for pediatric brain tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 study investigates the use of B7-H3-specific CAR T cells for treating children and young adults with diffuse intrinsic pontine glioma (DIPG), diffuse midline glioma (DMG), and recurrent or refractory central nervous system tumors. The approach involves collecting the patient's T cells, bioengineering them to target B7-H3-expressing tumor cells, and delivering them directly into the tumor site via a catheter. Patients will be assigned to different treatment arms based on their tumor type and location, allowing for tailored therapy. The study aims to assess the safety and efficacy of this innovative locoregional immunotherapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 1 and ≤ 26 years
2. Diagnosis of refractory or recurrent CNS disease for which there is no standard therapy, or diagnosis of DIPG or DMG at any time point following completion of standard therapy
3. Able to tolerate apheresis, or has apheresis product available for use in manufacturing
4. CNS reservoir catheter, such as an Ommaya or Rickham catheter
5. Life expectancy ≥ 8 weeks
6. Lansky or Karnofsky score ≥ 60
7. If patient does not have previously obtained apheresis product, patient must have discontinued, and recovered from acute toxic effects of, all prior chemotherapy, immunotherapy, and radiotherapy and discontinue the following prior to enrollment:

   1. ≥ 7 days post last chemotherapy/biologic therapy administration
   2. 3 half lives or 30 days, whichever is shorter post last dose of anti-tumor antibody therapy
   3. Must be at least 30 days from most recent cellular infusion
   4. All systemically administered corticosteroid treatment therapy must be stable or decreasing within 1 week prior to enrollment with maximum dexamethasone dose of 2.5 mg/m2/day. Corticosteroid physiologic replacement therapy is allowed.
8. Adequate organ function
9. Adequate laboratory values
10. Patients of childbearing/fathering potential must agree to use highly effective contraception

Exclusion Criteria:

1. Presence of Grade ≥ 3 cardiac dysfunction or symptomatic arrhythmia requiring intervention
2. Presence of primary immunodeficiency/bone marrow failure syndrome
3. Presence of clinical and/or radiographic evidence of impending herniation
4. Presence of \>Grade 3 dysphagia
5. Presence of active malignancy other than the primary CNS tumor under study
6. Presence of active severe infection
7. Receiving any anti-cancer agents or chemotherapy
8. Pregnant or breastfeeding
9. Subject and/or authorized legal representative unwilling or unable to provide consent/assent for participation in the 15 year follow up period
10. Presence of any condition that, in the opinion of the investigator, would prohibit the patient from undergoing treatment under this protocol

Where it's running

• Seattle Children's Hospital
  Seattle, Washington, United States Recruiting

Study contacts

• Study coordinator: Rebecca Ronsley, MD
• Email: CBDCIntake@seattlechildrens.org
• Phone: 206-987-2106

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• BCB-276 CAR T therapy for DIPG in children and young adults

  This study tests BCB-276, a patient's own CAR T cells against DIPG, after standard radiation, to see if it is safe and can help extend survival.

  Recruiting at 3 sites Phase 2 BrainChild Bio, Inc · Los Angeles, California and 5 other locations · NCT07680439

• CAR T-cell therapy for pediatric brain tumors

  This study is testing a new CAR T-cell therapy for kids and young adults with tough brain tumors to see if it can safely help them when other treatments have failed.

  Recruiting Phase 1 Bambino Gesù Hospital and Research Institute · Roma, Italy · NCT05298995

• B7-H3 CAR T cells for recurrent brain tumors in kids and young adults

  This early-phase trial tests a personalized CAR T-cell therapy called B7-H3 CAR T for children and young adults with recurrent or progressive brain tumors.

  Recruiting at 2 sites Phase 1 Dana-Farber Cancer Institute · Boston, Massachusetts and 1 other locations · NCT07390539

• Investigating genetic and molecular profiles of pediatric brain tumors in China

  This study is trying to understand the genetic makeup of brain tumors in children to see how it affects their treatment and recovery.

  Recruiting Beijing Tiantan Hospital · Beijing, Beijing Municipality · NCT05672043

• Observational assessment of treatment outcomes for patients with primary brain tumors

  This study looks at how well treatments work for people with rare primary brain tumors using new classification guidelines to see if they help doctors group patients better.

  Recruiting at 42 sites European Organisation for Research and Treatment of Cancer - EORTC · Innsbruck and 41 other locations · NCT05259605

• In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

  This early-phase trial tests a one-time in vivo CAR T-cell therapy (SL1617) for people with relapsed or refractory B-cell lymphoma to see if it is safe and tolerable.

  Recruiting Phase 1 Chinese PLA General Hospital · Beijing · NCT07775508

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.