This was a phase I dose escalation study of PHE885 which is a fully humanised anti-BCMA CAR T-cell product for patients with relapsed/refractory multiple myeloma. It’s produced using this novel T-Charge platform so it allows manufacturing in under 48 hours.
What was the study design?
This was a phase I dose escalation study looking at PHE885 in patients with relapsed and refractory multiple myeloma who had been exposed to at least two prior lines of therapy and had been exposed to an IMiD, a PI and an anti-CD38 antibody.
What were the results of the study?
It’s an autologous CAR T product targeting BCMA and we were able to manufacture the product using this novel approach that allows manufacturing to occur in under two days that will improve the return of product to patient, so will shorten the manufacturing period and allow patients to be treated faster. So we tested multiple cell doses ranging from 2.5 to 20 million cells in a total of 50 patients.
We were able to see a few things. First is that because this manufacturing approach was much shorter, the cells are ex vivo, are being grown ex vivo, for a much shorter period of time, they retain some of the more stem-like or memory-like properties within the T-cells, so we think they’re a little bit healthier and they may have better function, persistence and expansion. We saw very good expansion in patients so we can infuse as few as 2.5 million cells and see the cells expand within patients. We saw a very, very high response rate. So 98% of patients responded – there were 50 patients on study so only one patient did not respond to this treatment.
How can these results impact the treatment of r/r multiple myeloma (RRMM)?
We’ve made huge advances in the last few years in terms of developing CAR T-cell products for patients with relapsed and refractory myeloma. But one of the problems is that those cells take a fair amount of time to manufacture, often 6-8 weeks to return the product. There are many patients who have aggressive disease who just can’t wait that period of time. So developing a manufacturing process that is faster, we’ll be able to get these really effective therapies to patients who couldn’t otherwise get them.
Another big problem is that a lot of patients who receive CAR T-cells still relapse and so we need better products. So the goal here also is by making a T-cell product that maybe is a little bit healthier, that has more of a memory phenotype, maybe it will function better. We don’t have the follow-up to know whether or not that’s the case but that’s one of the hopes from this study as well.
