Smart Immune treats adult acute leukemia patient at final dose level in Phase I/II ReSET-02 trial

Smart Immune today announces the treatment of the first patient in the third and final dose cohort of the dose-escalation stage in its ReSET-02 trial. This is an important milestone in the evaluation of SMART101 in post-transplant hematology.

The ReSET-02 trial (NCT05768035) is a Phase I/II multi-center, open-label, dose-escalation study to assess the safety and efficacy of Smart Immune’s lead asset, SMART101, an allogeneic T cell progenitor therapy, after allogeneic HSCT with post-transplant cyclophosphamide (PTCy), in adult patients with acute lymphoid leukemia. The trial has progressed to the final dose (9.0 x 10⁶ CD7⁺ cells per kg of body weight) cohort after favorable safety profiles observed in patients treated with the first and second dose levels. The product candidate is designed to accelerate T cell reconstitution to fight relapse and infection and improve overall and disease-free survival post-transplant.

Karine Rossignol, CEO and Co-founder, Smart Immune said: “We are thrilled to achieve this key milestone in our ReSET-02 trial after observing an excellent tolerability and safety profile with no dose limiting toxicities or safety issues with the first two dose levels. Reaching the final dose brings us a step closer in our efforts to quickly reset the immune system with a new fit T cell compartment, improving clinical outcomes in patients with high-risk cancers. Encouragingly, all preliminary immune reconstitution data, even in patients aged 50-70 years, point in the right direction.”  

No related safety events have been reported to date in the ReSET-02 trial. This encouraging safety profile is further confirmed by the other Smart Immune-sponsored trial data in Europe and the US.

SMART101 is an allogeneic cell therapy produced from healthy donor mobilized peripheral blood stem cells (CD34⁺) differentiated into T cell progenitors. It has been granted Orphan Drug Designation (ODD) by the European Medicines Agency and the US Food and Drug Administration (FDA), in addition to Fast Track Designation by the FDA, as a treatment to enhance clinical outcomes in patients receiving allo-HSCT.

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The full press release is available below, in English and in French.