Loc3CAR: B7-H3-CAR T Cells for Pediatric Brain Tumors
This study, called Loc3CAR, is testing a new treatment for children and young adults (up to 21 years old) with certain types of primary brain tumors. The treatment uses B7-H3-CAR T cells, which are your own immune cells specially modified to fight cancer. These cells are delivered directly into the brain through a catheter. The study aims to find the highest safe dose of B7-H3-CAR T cells. Participants will receive four infusions over four weeks. This is a Phase 1 study, meaning it's focused on safety and dosage. The study is currently unclear on its recruitment status and plans to enroll 29 participants.
- Study design
- This is a Phase 1 interventional study with a planned enrollment of 29 participants, divided into two groups based on their tumor type. It uses a 3+3 study design to evaluate safety and dosage.
- What's involved
- Participants will receive four B7-H3-CAR T cell infusions over a four-week period, administered via a CNS reservoir catheter.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 1 year after the last B7-H3-CAR T cell infusion, and then for a total of 15 years post-infusion on a long-term follow-up protocol.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05835687
Loc3CAR: Locoregional Delivery of B7-H3-CAR T Cells for Pediatric Patients With Primary CNS Tumors
Active, Not Recruiting
PHASE1Up to 21InterventionalTreatmentSt. Jude Children's Research HospitalInvestigator-initiated
~29 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:B7-H3-CAR T cells
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum tolerated dose (MTD)
Measured over Four (4) weeks after the first B7-H3-CAR T-cell infusion or 7 days after the fourth B7-H3-CAR T cell infusion, whichever is longer
Conditions
Where it's being run
1 sites across 1 statesTennessee1
Study leadership
- Christopher DeRenzo, MD · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital
- Kelsey Bertrand, MD, MSc · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital
- Giedre Krenciute, PhD · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Adequate tumor tissue from primary tumor resection or biopsy for central pathology review (i.e., B7-H3 expression evaluation by immunohistochemistry \[IHC\] or H3K27M mutation if pontine lesion)
Has a diagnosis of diffuse midline glioma that harbors a mutation associated with this entity (e.g. H3K27M)
Has presumptive/suspected brainstem high-grade neoplasm with available imaging for central imaging review 5. Life expectancy of \> 12 weeks 6. Adult patient, parent or legal guardian can understand and is willing to sign a written informed consent document according to institutional guidelines
Cohort A: relapsed/refractory non-brainstem CNS primary tumor AND tumor is B7-H3 positive
Cohort B: Diffuse midline glioma AND tumor is:
B7-H3 positive if non-pontine
OR H3K27-altered diffuse midline pontine glioma
OR radiographically-confirmed classic/typical DIPG 3. Estimated life expectancy of \>12 weeks 4. Karnofsky or Lansky performance score ≥50 5. Participant of childbearing/child-fathering potential agrees to use contraception 6. For females of childbearing age:
Not pregnant with negative serum pregnancy test
Not lactating with intent to breastfeed 7. Chemotherapy/biologic therapy must be discontinued ≥ 7 days prior to enrollment 8. The last dose of antibody therapy (including check point inhibitor) must be at least 3 half-lives or 30 days, whichever is shorter, from the time of enrollment 9. At least 30 days from most recent cell infusion prior to enrollment. 10. All systemically administered corticosteroid therapy must be stable or decreasing for ≥1 week prior to enrollment, with a maximum dexamethasone dose of 2.8 mg/m\^2/day 11. Meets eligibility for apheresis, or has an apheresis product previously collected at a FACT-accredited program 12. Adult patient, parent or legal guardian can understand and is willing to sign a written informed consent document according to institutional guidelines
Relapsed/refractory non-brainstem CNS primary tumor
Tumor must be considered B7-H3 positive
Diffuse Midline Glioma - Must meet one of the following criteria
Tumor is considered B7-H3 positive
H3K27-altered diffuse midline pontine glioma
Radiographically-confirmed classic/typical DIPG
Must complete standard radiation prior to Loc3CAR treatment and be a minimum of 6 weeks post-completion of radiation therapy
Radiation therapy: ≥ 6 weeks
Bevacizumab: ≥ 28 days
Cytotoxic chemotherapy: ≥ 21 days
Biologic agents: ≥ 7 days
Antibody therapy: ≥ 3 half-lives or 30 days (whichever is shorter)
Cellular therapy: ≥ 30 days
Investigational agent: ≥ 3 half-lives or 30 days (whichever is shorter)
Corticosteroids: All systemically administered therapy must be stable or decreasing for ≥ 1 week prior to enrollment, with a maximum dexamethasone dose of 2.8 mg/m\^2/day. Corticosteroid physiologic replacement therapy for management of pituitary/adrenal axis insufficiency and/or topical administration (e.g. inhaled or dermatologic) is allowed. 7. Estimated life expectancy of \>8 weeks 8. Karnofsky or Lansky performance score ≥ 50 9. Echocardiogram with a left ventricular ejection fraction ≥ 50% 10. Adequate renal function defined as calculated creatinine clearance or radioisotope GFR ≥ 50 mL/min/1.73m\^2. 11. Adequate pulmonary function defined as forced vital capacity (FVC) ≥50% of predicted value or pulse oximetry ≥90% on room air. 12. Total Bilirubin ≤3 times the upper limit of normal for age. 13. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 times the upper limit of normal for age. 14. Hemoglobin \>8.0 g/dL (can be transfused). 15. Platelet count \>50,000/mm\^3 (can be transfused). 16. Absolute neutrophil count (ANC) ≥1000/uL. 17. Taking anti-seizure medication, or agrees to initiate anti-seizure medication prior to starting study therapy. 18. Has recovered from all NCI CTAE grade III-IV, non-hematologic acute toxicities from prior therapy. 19. Male participants of child-fathering potential agree to use contraception 20. Female participants of childbearing potential:
Negative serum pregnancy test within 7 days prior to infusion
Not lactating with intent to breastfeed
If sexually active, agrees to use birth control until 3 months after T-cell infusion. Male partners should use a condom 21. Adult patient, parent or legal guardian can understand and is willing to sign a written informed consent document according to institutional guidelines
What this trial measures
- Maximum tolerated dose (MTD)Four (4) weeks after the first B7-H3-CAR T-cell infusion or 7 days after the fourth B7-H3-CAR T cell infusion, whichever is longer
To determine the maximum tolerated dose for the locoregional delivery of autologous B7-H3-CAR T cells in patients with recurrent/refractory B7-H3- positive primary CNS tumors (Cohort A) or diffuse midline glioma (DMG) (Cohort B).