Loc3CAR: Locoregional Delivery of B7-H3-CAR T Cells for Pediatric Patients With Primary CNS Tumors (NCT05835687) | Clinical Trial Compass
RecruitingPhase 1
Loc3CAR: Locoregional Delivery of B7-H3-CAR T Cells for Pediatric Patients With Primary CNS Tumors
United States48 participantsStarted 2023-04-27
Plain-language summary
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).
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
✓. Age ≤ 21 years of age
✓. Primary CNS tumor
✓. For Cohort A, must have evidence of relapsed or refractory non-brainstem CNS tumor
✓. For Cohort B, must meet one of the following criteria:
✓. Life expectancy of \> 12 weeks
✓. Adult patient, parent or legal guardian can understand and is willing to sign a written informed consent document according to institutional guidelines
Exclusion criteria
✕. Age ≤ 21 years of age
✕. Primary CNS tumor with measurable or evaluable disease and meets criteria for either Cohort A or B:
✕. Estimated life expectancy of \>12 weeks
✕. Karnofsky or Lansky performance score ≥50
✕
What they're measuring
1
Maximum tolerated dose (MTD)
Timeframe: 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
. Participant of childbearing/child-fathering potential agrees to use contraception
✕. For females of childbearing age:
✕. Chemotherapy/biologic therapy must be discontinued ≥ 7 days prior to enrollment
✕. 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