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New treatment option for Central Nervous System Tumor
Official title Study of B7-H3-Specific CAR T Cell Locoregional Immunotherapy for Diffuse Intrinsic Pontine Glioma/Diffuse Midline Glioma and Recurrent or Refractory Pediatric Central Nervous System Tumors
ClinicalTrials.gov ID: NCT04185038
What this study is testing
What is SCRI-CARB7H3(s); B7H3-specific chimeric antigen receptor (CAR) T cel?
SCRI-CARB7H3(s); B7H3-specific chimeric antigen receptor (CAR) T cel is an investigational medicine, given as an once-weekly, being studied as a potential treatment for central nervous system tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 1 study of central nervous system (CNS) locoregional adoptive therapy with autologous CD4+ and CD8+ T cells lentivirally transduced to express a B7H3-specific chimeric antigen receptor (CAR) and EGFRt. CAR T cells are delivered via an indwelling catheter into the tumor resection cavity or ventricular system in children and young adults with diffuse intrinsic pontine glioma (DIPG), diffuse midline glioma (DMG), and recurrent or refractory CNS tumors.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 26
You may be able to join if
- Age ≥ 1 and ≤ 26 years
- 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...
- Able to tolerate apheresis, or has apheresis product available for use in manufacturing
- CNS reservoir catheter, such as an Ommaya or Rickham catheter
- Life expectancy ≥ 8 weeks
You likely can't join if
- Presence of Grade ≥ 3 cardiac dysfunction or symptomatic arrhythmia requiring intervention
- Presence of primary immunodeficiency/bone marrow failure syndrome
- Presence of clinical and/or radiographic evidence of impending herniation
- Presence of \>Grade 3 dysphagia
- Presence of active malignancy other than the primary CNS tumor under study
- Presence of active severe infection
See the full eligibility criteria
- Age ≥ 1 and ≤ 26 years
- 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
- Able to tolerate apheresis, or has apheresis product available for use in manufacturing
- CNS reservoir catheter, such as an Ommaya or Rickham catheter
- Life expectancy ≥ 8 weeks
- Lansky or Karnofsky score ≥ 60
- 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...
- ≥ 7 days post last chemotherapy/biologic therapy administration
- 3 half lives or 30 days, whichever is shorter post last dose of anti-tumor antibody therapy
- Must be at least 30 days from most recent cellular infusion
- 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...
- Adequate organ function
- Adequate laboratory values
- Patients of childbearing/fathering potential must agree to use highly effective contraception
- Presence of Grade ≥ 3 cardiac dysfunction or symptomatic arrhythmia requiring intervention
- Presence of primary immunodeficiency/bone marrow failure syndrome
- Presence of clinical and/or radiographic evidence of impending herniation
- Presence of \>Grade 3 dysphagia
- Presence of active malignancy other than the primary CNS tumor under study
- Presence of active severe infection
- Receiving any anti-cancer agents or chemotherapy
- Pregnant or breastfeeding
- Subject and/or authorized legal representative unwilling or unable to provide consent/assent for participation in the 15 year follow up period
- Presence of any condition that, in the opinion of the investigator, would prohibit the patient from undergoing treatment under this protocol
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 26 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.