ASCO 2025 | TRAVERSE: ALLO-316, a CAR-T cell therapy, in pre-treated advanced ccRCC

We are very excited to present this year the updated results from the TRAVERSE study at ASCO 2025. This is the first in human phase 1 clinical trial for ALLO-316, which is a CD70 allogeneic CAR-T cell product targeting CD70 antigen expressing tumors. This Allo316 study was specifically designed for patients with clear cell renal cell carcinoma. For this particular meeting, we are presenting our Phase Ib data. Basically, from the Phase Ia data, we established dose level 2 at 80 million of CAR T cells as our expansion dose. And to that point, we have enrolled 22 patients on the Phase Ib. 20 of these patients infused the ALLO-316 product. The other two patients received lymphodepletion, but they never were able to receive the ALLO-316. So the primary endpoint from this Phase Ib was safety, and this endpoint was looking at the efficacy data and the cell kinetics of the Allo316. As far as the safety, overall the safety profile was, I would say, manageable and consistent with what we see in other CAR-T cell products, especially the commercialized one for heme malignancies. For instance, if you look at the cytopenias, they were around the same range that we see in the heme malignancies. If you look at the cytokine release syndrome, which is something, a unique toxicity for the CAR-T cell products, it was around 68%. All the cases were grade one or two. Same thing for ICANS, which is a unique neurotoxicity associated with CAR-T cell products. We have around 18 percent. All of them were grade one or two and reversible. We did not see any graft-versus-host disease because, remember, compared to the commercially available products, this is an allogeneic off the shelf from donated cells. To that point, we didn’t see any graft-versus-host disease. The infection rates were also consistent with what we see in hematologic malignancies. One, I would say, probably more frequent toxicity we saw in our program is something we call HLH in the setting of CAR T-Cell product under, you know, we call it ICANS. So this is something recently more recognized in the CAR T-Cell field and at once was considered very serious complication. From our phase 1a data, we have learned a lot how to manage this toxicity and indeed for the phase 1b, although the incidence was 36%, none of these toxicities met the DLT criteria because we were able to manage the capture very early and treat them properly. And from these 36%, only two patients had grade three or four. Most of the patients we captured early and they were at the grade one or two treated them successfully.

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