The safety profile in terms of CRS, ICANS and DLTs observed is in line with previously reported observations. We intend to present data on up to 42 pts, with a data cut-off of 10.09.2023.
We intend to submit efficacy, safety and CAR T-cell pharmacokinetics data from 5 cohorts treated with 1x106, 1x107 or 1x108 CLDN6 CAR-T cells ± CARVac with a data cut-off of March 14th, 2023 from ≥17 treated patients as a late-breaking abstract. Clinical trial information: NCT04503278.
CLDN6 CAR-T cells ± CARVac show an acceptable safety profile at doses tested and encouraging signs of clinical activity. Data from the completed dose escalation phase will be presented. Acknowledgements: BNT211-01 is funded by BioNTech Cell & Gene Therapies GmbH.Trial registration: Clinicaltrials.gov: NCT04503278.Ethics approval: Ethics & Institutional Review Board approvals were obtained from the respective participating countries prior to initiation of the trial.
Manageable cytokine release syndrome (CRS, grade 1-2, the latter managed with Tocilizumab) without any signs of neurotoxicity have been observed in both patients of part 1 DL2. Updated data from open cohorts and especially for combination with CARVac will be presented. Clinicaltrials gov: NCT04503278
over 2 years ago
P1/2 data • Preclinical • Late-breaking abstract • CAR T-Cell Therapy
"Robust engraftment of CLDN6 CAR-T cells and first signs of efficacy could already be observed in initial dose cohort. Enrollment into higher dose levels and cohorts for combination with CARVac is currently ongoing."