Hi, I'm Doctor Shambavi Richard.
I'm a myeloma physician at Mount Sinai in New York, and my, special area of interest is myeloma, Car-T therapy.
Today I want to talk about the very exciting preliminary results of the phase 1b/2 DURGA-1 trial, which, was, testing out a new dual target, autologous Car-T product.
This targets two different antigens on the myeloma cells, BCMA and CD19.
BCMA is present on the majority of malignant plasma cells.
CD19, on the other hand, is present on B cells, and some subsets of myeloma cells and progenitor cells, and the idea is that it may be targeting a so-called myeloma stem cell or myeloma progenitor cell, just thus reducing risks of antigen negative relapses.
The other, cool thing with this Car-T product is that it has a different manufacturing technology.
So while traditional manufacturing, takes several weeks for Car-T cells to be made this particular fast car platform makes the Car-T cells in less than three days, so potentially making it available to more patients who need a Car-T
and also because of this different technology, which eliminates x vivo expansion, the Car-T cells are much younger and fitter.
More naive because they're going through less processing.
And it the cells just go through activation and transduction, and all the expansion happens in vivo.
So this also improves, safety and tolerability.
In fact, on this study, about a third of the patients received the Car-T infusion as an outpatient.
In terms of safety, the majority of adverse events were hematologic cytopenias.
And, they were very tolerable.
Infections were very low at less than 10% grade three infections.
And there were no deaths or dose limiting toxicities.
In terms of efficacy at this short follow up of 3.9 months.
Overall response rate was 96%.
CR and better rates were 78%.
and partial response was 17%.
So very exciting early data.
And in addition, the MRD, in the MRD evaluable patients, 94% MRD negative, the median time to first response was one month.
And responses deepened over time.
Interestingly, there was a small group of patients who had had a prior BCMA Car-T, and in this group of patients, responses were 100% and CR better was 80%.
So obviously giving new hope to patients who have had a prior BCMA Car-T and then relapsed after it.
So really, a lot of hope for this new Car-T product.
As we get more updates on further efficacy and, evaluation.
One additional thing I wanted to say that's very important is that there were no delayed, toxicities seen with this product.
No delayed neurotoxicity, no Parkinson's, no colitis, no Guillain-Barré.
So really, even in terms of acute neurotoxicity, ICANS, as we call it, there was only one patient who had a grade one ICANS in this entire study,
including, a prior study with, and it were in this particular product was tested.
So we're looking ahead to, encouraging times and more hope with this Car-T product.
And in addition, the CRS rates were very, very tolerable.
They all the the vast majority, 15 of the 16 patients on this 26 patients study who had a CRS were grade one CRS, and there was only one grade two CRS.
So really the, toxicities seemed to be very manageable with this product.
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HealthTree • December 19, 2025