This first in human, phase I clinical trial was exploring a novel new CD70 allogeneic CAR-T cell product in patients who have relapsed refractory metastatic kidney cancer. The study followed a 3+3 study design. We are exploring in this study four different dose levels, ranging from 40,000,000 to 240,000,000 of the CD70 CAR-T cell ALLO-316. We reached the third dose level in this study and we continue to accrue.
The main results from this early phase clinical trial, we did not find any concerning safety signals outside what we usually see in the autologous CAR-T cell products. For instance, the cytokine release syndrome, CRS, was around 58% and the majority of these patients except one were low-grade CRS. One patient had a grade 3 which was manageable as well. Other than that, most of the side effects were as expected with the autologous CAR-T cells. But when it comes to the secondary endpoint, the anti-tumour activity, we were very encouraged with this study being in the early phase, we were very encouraged with the efficacy results we have seen so far in the first 19 patients we treated. Of these 19 patients, 18 patients were evaluable for efficacy and if you look at the disease control rate for the patients who have CD70 positive expression, that was 100%, and then the objective response rate was 30%. Again, these results are early prelim but very encouraging, especially taking into account that those results, response rates and disease control, were at low dose levels. Most of these patients received dose levels 1 and 2; we didn’t reach yet to the highest dose level 4.
The study continues to accrue across several centres in the United States. Our goal is by the end of 2023 to finish the dose escalation phase and find the optimum expansion and phase II dose. We also hope to include more disease subtypes, not just patients with renal cell carcinoma, in the expansion cohort.
I want to end up by saying we are really very encouraged by the data from the first in human clinical trials, particularly the very encouraging response rates we have seen at the low dose levels: 100% disease control rate and 30% objective response rate in patients who are heavily pre-treated with relapsed refractory renal cell carcinoma is very, very encouraging to see. These data highlight the potential for an allogeneic CAR-T cell product really much needed for patients with kidney cancer and hopefully other cancers.
These data from the TRAVERSE study provide a proof of concept that CAR-T cell therapy can hopefully be a potential treatment for patients with kidney cancer and other tumours.