Actively Recruiting
Loc3CAR: Locoregional Delivery of B7-H3-CAR T Cells for Pediatric Patients With Primary CNS Tumors
Led by St. Jude Children's Research Hospital · Updated on 2026-05-05
48
Participants Needed
1
Research Sites
252 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Loc3CAR is a Phase I clinical trial evaluating the use of autologous B7-H3-CAR T cells for participants ≤ 21 years old with primary CNS neoplasms. B7-H3-CAR T cells will be locoregionally administered via a CNS reservoir catheter. Study participants will be divided into two cohorts: cohort A with B7-H3-positive relapsed/refractory non-brainstem primary CNS tumors, and cohort B with diffuse midline gliomas (DMG). Participants will receive four (4) B7-H3-CAR T cell infusions over a 4 week period. The purpose of this study is to find the maximum (highest) dose of B7-H3-CAR T cells that are safe to give patients with primary brain tumors. Primary objectives * To determine the safety, maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) for the locoregional delivery of autologous B7-H3-CAR T cells in patients ≤ 21 years of age with recurrent/refractory B7-H3+ primary CNS tumors (Cohort A) or DMG (Cohort B). Secondary objectives * To assess the efficacy, defined as sustained objective response, a partial response (PR) or complete response (CR) observed anytime on active treatment with B7-H3-CAR T cells in patients with relapsed/refractory B7-H3+ primary CNS tumors (Cohort A) or DMG (Cohort B). * To characterize and monitor neurologic toxicities in patients while on study (Cohort A and B).
CONDITIONS
Official Title
Loc3CAR: Locoregional Delivery of B7-H3-CAR T Cells for Pediatric Patients With Primary CNS Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 years or younger
- Diagnosis of a primary CNS tumor
- For Cohort A: evidence of relapsed or refractory non-brainstem CNS tumor
- For Cohort B: diffuse midline glioma with adequate tumor tissue for pathology review or diagnosis with H3K27M mutation or suspected brainstem high-grade neoplasm with imaging
- Life expectancy greater than 12 weeks
- Ability to understand and sign informed consent
- Measurable or evaluable disease meeting cohort criteria
- Tumor is B7-H3 positive (Cohort A) or meets specific molecular or radiographic criteria (Cohort B)
- Karnofsky or Lansky performance score 50 or higher
- Use of contraception if of childbearing or child-fathering potential
- Not pregnant or lactating for females of childbearing age
- Discontinuation of chemotherapy, biologic therapy, antibody therapy, corticosteroids, and other specified treatments for defined washout periods prior to enrollment
- Availability of autologous T-cell product meeting GMP criteria
- Presence of CNS reservoir catheter or programmable shunt
- First CAR T cell infusion scheduled at least 5 days after CNS surgery
- Adequate cardiac, renal, pulmonary, and liver function
- Taking or agreeing to take anti-seizure medication
- Recovery from severe toxicities from prior therapy
- Willingness to participate in a 15-year long-term follow-up
You will not qualify if you...
- Presence of other significant medical disorders that would interfere with treatment or study procedures
- Known primary or acquired immunodeficiency
- Known HIV infection
- Severe ongoing bacterial, viral, or fungal infections
- Rapidly progressive disease
- Medical conditions that would prevent or confound study participation
- Unwillingness or inability to provide consent for long-term follow-up
- Presence of non-programmable shunts or reservoir catheters that could compromise therapy or safety
- Recent myocardial infarction, unstable angina, severe heart failure, myocarditis, or significant arrhythmias within 6 months
- Receiving prohibited therapies during specified washout periods
- Receipt of live vaccines within 30 days
- Uncontrolled hypertension or seizures
- Pregnancy or intention to breastfeed
AI-Screening
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Trial Site Locations
Total: 1 location
1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
Research Team
T
Tabatha E. Doyle, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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