Hi, I'm Dr. Azra Borogovac. I'm from City of Hope and I'm going to be presenting our abstract on safety and efficacy of out-of-specification silta cell products in relapse refractory multiple myeloma. So as we know, CAR T cell has revolutionized the way that we treat relapse refractory multiple myeloma and silta-captogene autolusil or silta cell is approved after one or more lines of therapy in that space. So in commercial manufacturing, some products fail to meet the FDA specified criteria. They're also called out-of-specification products and some products result in manufacturing failure. So FDA has specific criteria that they have for CAR T cell products in order for them to be released under a FDA approved or standard of care product. And some products fail to meet those specific criteria. Those may include having a too low of a cell dose, having too low of a CAR expression, having something called too low of a viability of the cells or something called too low of IL interferon gamma release. Those criteria are all meant to evaluate how good the product is. And so some out-of-spec products don't meet the exact criteria that the FDA has predefined. Even though those out-of-specification products can be given under a program called the Expanded Access Program, clinicians sometimes really have no clue whether to give those products and how they perform compared to standard of care products. And out-of-spec products can also delay CAR T delivery and can also impact insurance approvals. And so we wanted to conduct a study to compare these out-of-spec products compared to in-specification standard of care products. And so we included any patient who got collection for CAR T cell between April of 2022 and April of 2025 at City of Hoh. And we ended up seeing that around 16.5% of all patients who got collection had an out-of-spec product and around 3% had manufacturing failure. And so out of all those patients, we had about 23 that received their out-of-spec product and we had about 134 that received a standard of care product. And so we were able to compare the two. And what we saw overall is that the two groups did not have any difference in terms of their safety. So cytokine release syndrome, neurotoxicity was comparable between the two groups and there was no new safety signals. In terms of efficacy, we saw that the overall response rates again were very similar. We found a 91% overall response rate in the out-of-spec products compared to 92.5 in the standard of care products. And then we also looked at something called progression-free survival or time to progression. And we also looked at overall survival. And at a median of follow-up of around 13.1 months, we found no difference between the two groups. So the 12-month progression-free survival of the out-of-spec group was around 72% compared to 76% in the out-of-spec group. And the overall survival at 12 months was around 89.5 versus 85% between the two groups, but they were not statistically different. We also did an exploratory analysis to see if there were any risk factors that were associated with out-of-spec products. And we found that prior exposure to bispecific antibodies may be associated with having an out-of-spec product if they were given those bispecific antibodies prior to collection. And so in conclusion, this study really helps clinicians in that it shows them that out-of-spec products have comparable safety as well as early efficacy as standard of care products and may help them make time-sensitive decisions and otherwise hard to treat patients. If our videos have helped you in any way and you're able to, please consider making a donation to help us continue this important work. Your gift will go three times as far when we reach $500,000 by the end of the year. Every contribution, big or small, makes a difference and we're deeply grateful for your support.
HealthTree • December 20, 2025