NCT05835687 Loc3CAR: Locoregional Delivery of B7-H3-CAR T Cells for Pediatric Patients With Primary CNS Tumors
| NCT ID | NCT05835687 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | St. Jude Children's Research Hospital |
| Condition | Central Nervous System Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2023-04-27 |
| Primary Completion | 2028-03 |
Trial Parameters
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Brief 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).
Eligibility Criteria
Inclusion Criteria: Screening Eligibility 1. Age ≤ 21 years of age 2. Primary CNS tumor 3. For Cohort A, must have evidence of relapsed or refractory non-brainstem CNS tumor 4. For Cohort B, must meet one of the following criteria: * 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 Exclusion Criteria: Screening Eligibility All Participants 1\. Participant has other clinically significant medical disorders (e.g. serious infections or significan