The Loc3CAR Phase I clinical trial (NCT05835687) is an exciting development in the treatment of pediatric primary central nervous system (CNS) neoplasms. It focuses on the use of autologous B7-H3-CAR T cells, delivered directly to the CNS via a specialized catheter. The study comprises two cohorts: cohort A, which includes patients with B7-H3-positive relapsed or refractory non-brainstem primary CNS tumors, and cohort B, for those with high-grade neoplasms in the brainstem.
Participants in the trial will undergo six B7-H3-CAR T cell infusions over an 8-week period. Importantly, this treatment is administered without lymphodepleting chemotherapy. The primary objectives of the study are to assess the safety and determine the maximum tolerated dose (MTD) of B7-H3-CAR T cells. The trial will utilize a 3+3 study design and an 8-week evaluation period. The entire study will span one year, after which patients will transition to an established long-term follow-up protocol.
This innovative trial offers hope for pediatric patients with primary CNS tumors, including atypical teratoid/rhabdoid tumors, diffuse midline gliomas with H3 K27M mutations, and ependymomas. It represents a promising avenue in the quest for improved treatment options for these challenging conditions.
If you or a family member are interested in participating in this clinical trial or would like to gather additional information about it, EBCI is here to assist you in connecting with the Principal Investigators or research facilities located near you. Please feel free to get in touch with Shreya Prakash by emailing her at firstname.lastname@example.org or calling/texting 425-436-8688. Alternatively, you can complete our Patient Interest Form, and EBCI will contact you.