BioNTech Reports Preliminary Phase I/II Trial Results for CAR T-Cell Therapy
BioNTech announced preliminary results from its Phase I/II trial of Claudin 6-targeted CAR T-cell therapy and CarVAC mRNA booster at the ESMO conference.
BioNTech has announced preliminary results from its Phase I/II trial evaluating BNT211-01, a combination of Claudin 6 (CLDN6)-targeted CAR T-cell therapy and the mRNA-based CAR T booster CarVAC. The findings were presented at the European Society for Medical Oncology (ESMO) Conference in Madrid on October 24, 2023.
The study treated 38 patients with ovarian cancer and germ cell tumors as of July 25, 2023. Of these, 23 patients (61%) experienced Grade 3 or higher treatment-emergent adverse events (TEAEs), with 20 (53%) related to the CAR T-cells themselves. Nine patients treated with the combination therapy reported TEAEs above Grade three related to both drugs, and two (10%) to CarVAC. Dose-limiting toxicities occurred in two patients across different cohorts, preventing the determination of a maximum tolerated dose (MTD). One treatment-related death was reported after the data cutoff.
Cytokine release syndrome, a common side effect of CAR T-cell therapy, was predominantly Grade 1 or 2 (95%) and observed in 18 (47%) patients. The therapy demonstrated acceptable safety and tolerability with early indications of efficacy in solid tumors. The CAR T-cells used in the treatment were produced via an automated process.
BioNTech continues to assess the safety and efficacy of this combined therapeutic approach for solid tumors.