CAR-T Meeting 2026 | A Phase I trial of CD19/CD22 bicistronic CAR T-cells in pediatric and AYA patients with R/R B-ALL
In this video, Alexandra Dreyzin, MD, National Institutes of Health, Bethesda, MD, discusses a Phase I trial (NCT05442515) investigating CD19/CD22 bicistronic CAR T-cells in pediatric and adolescent and young adult (AYA) patients with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL), highlighting the potency of this novel construct. This interview took place at the EBMT-EHA 8th European CAR T-cell Meeting, held in Palma de Mallorca, Spain.
These works are owned by Magdalen Medical Publishing (MMP) and are protected by copyright laws and treaties around the world. All rights are reserved.
Transcript
So we are really excited by the results for this trial. It’s a phase one trial of a bicistronic CAR that is a second iteration from a previous 19/22 CAR that our group had designed. And this one is really quite potent. It’s made from a single vector that’s transduced into the cells, and then it makes two independent CARs, a CD19 that’s linked to CD20, and then the CD22 that’s linked to 4-1BB...
So we are really excited by the results for this trial. It’s a phase one trial of a bicistronic CAR that is a second iteration from a previous 19/22 CAR that our group had designed. And this one is really quite potent. It’s made from a single vector that’s transduced into the cells, and then it makes two independent CARs, a CD19 that’s linked to CD20, and then the CD22 that’s linked to 4-1BB. And so with that, we’ve seen really great potency with both CD19 and CD22 activity. We have learned a lot of lessons from this trial. The initial four patients treated at our starting dose of a million cells per kilo demonstrated efficacy, but also demonstrated some significant toxicities, including cytokine release syndrome and neurotoxicity. And after seeing the severe neurotoxicity, especially with high disease burden, we paused the trial, de-escalated the dose, and redesigned the cohort so that we’re now looking at patients based on their baseline disease burden. So we have a low and a high disease cohort. Of the 11 patients treated so far, there’s been 100% MRD negative complete response rate, and that includes both bone marrow disease and extramedullary disease.
This transcript is AI-generated. While we strive for accuracy, please verify this copy with the video.
Read more...
