Clinical Trial Results for Novel Academic Anti-BCMA Myeloma CAR-T Cell | Yael Cohen, MD | IMS 2024

Hi, my name is Yael Cohen and I'm a physician from Israel from Tel Aviv Medical Center. And this morning I reported on behalf of the Hadassah medical team in Jerusalem, results of a study with an academic CAR-T, it's turned HBI 0101 and reported results of 84 patients who received the high dose from this CAR-T. So as you probably know, this audience, CAR-T has been revolutionizing treatment in myeloma and really offers unprecedented efficacy for patients. However, there is a great challenge with the availability of this treatment, with slot availability, with vein-to-vein times, and also, of course, the costs. And in many places in the world, this is really not available and that is why there is a need to think about how this important resource can be accessed to patients. What was done in this study? It was to develop a CAR-T, an academic CAR-T, not by pharmaceuticals, so this was a joint development of the Bar-Ilan University in Israel together with Hadassah Medical Center. This is a BCMA targeted CAR-T and it was first tested in a phase one trial, this has actually been already reported, and then the trial continued and accrued 84 patients at the high dose, so this was 800 million CAR-T cells per patient. And the findings are really encouraging. The overall response rate was 92% and the progression free survival was 11.6% a month. So these are quite comparable, for example, to the BCMA CAR-T and it should be noted that the population that was included in this trial was with a more severe characteristic, so the inclusion criteria were much broader. For example, patients could have a quite advanced renal failure, a clearance of 20, that's never allowed in pharma trials. The platelet counts of 30,000, that's much lower than it's usually acceptable. They could have a lower performance status and even though these patients could be in worse condition, and actually half the patients enrolled in the study would have not made it for inclusion, not to CARMA study, not to CAR-T1 study. Nevertheless, still the results were very optimistic. So this is what we call a point of care academic CAR-T and I think this offers another solution possibly for patients throughout the world. There are other centers, there's also a Spanish program and others that have academic CAR-Ts and hopefully this will allow for a broader access to patients.