ASH 2025 | Phase I trial of CLN-049, a novel anti-FLT3 x anti-CD3 bispecific T-cell engager, in R/R AML

So this is one of the novel approaches in AML using a BiTE which is a bispecific. Basically the idea is we all have cancer cells and some of our cancer cells misbehave and how can we re-engineer our immune system to be able to see our cancer cells to tackle them. And this is what bispecific is – your own T-cells, which is your own good immune system, and attach it to the leukemic cells to get rid of the leukemic cells. In that particular study, we looked into FLT3, which is actually present on about 80% of cells. So it’s a very appealing target for us to connect our CD3, which is T-cells, to attack the FLT3 acute leukemic cells. And you don’t need to be FLT3 mutated. You could be FLT3 wild type because it’s 80% of AML patients – the myeloblasts expressed FLT3. And what we saw in this study, actually, we saw it’s very well tolerated, very low toxicity profile, and at the same time, we saw very good efficacy. So this is a monotherapy, and in our study, we had 45 patients enrolled. We saw 31% CR or CRh, which is for a monotherapy phase one, very exciting outcomes. These patients were extremely pre-treated. Some patients had up to eight lines of therapy and we still saw about one set of our patients achieving CR and CRh. In addition, for that, the safety profile was so low we only saw one grade three CRS, cytokine release syndrome, and the grade three CRS we were able to mitigate it moving forward by having a two-step up dose instead of one step up dose, and once we moved to the two-step up dose, we really saw no CRS, grade three. We did not see any transaminitis or any ICANS. And that really was great outcomes that actually the company, Cullinan and us, we are moving into – we submitted for an FDA fast track.

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