January 23, 2023

1st leukemia patient dosed with SMART101 at MSK

Phase I/II trial will assess safety and efficacy ofSMART101 in accelerating immune reconstitution to fight infection and relapse  

Smart Immune announced today that the first adult leukemia patient has been dosed with SMART101, a T-cell progenitor cell injection derived from donor stem cells using ProTcell at Memorial SloanKettering Cancer Center (MSK).

The PhaseI/II trial (NCT04959903) is a multicenter, open-label, first-in-human study expected to enrol up to 36 adult and pediatric patients with haematological malignancies, and has been designed to assess the safety and the potential of SMART101 to improve clinical outcomes of hematopoietic stem cell transplantation (HSCT).

The first enrolled patient received a SMART101 injection in December 2022; no related adverse events have been reported.

Dr Frédéric Lehmann, Chief Medical Officer of Smart Immune, said, “The infusion of the first patient is a significant milestone in our journey to address the challenge of slow immune reconstitution after allogeneic HSCT, using the power of the thymus. We are grateful to the dedicated investigators at MSK and look forward to continuing enrolment in this important trial.”

Karine Rossignol, Chief Executive Officer and Co-founder of SmartImmune, said: “We are excited to sponsor this pioneering trial. Accelerated reconstitution of a full polyclonal T-cell repertoire after stem cell transplantation could improve both quality of life and clinical outcomes for patients with acute leukemia, and we look forward to releasing more data as the trial progresses.”


About SMART101

SMART101 is generated ex vivo in 7 days from allogeneic bloodstem cells, using Smart Immune’s ProTcell T-cell therapy platform. Once injected into the patient, the SMART101 human T-cell progenitors travel to the thymus where they are educated to become fully functional and self-tolerant T-cells. Preclinical data suggest that the ProTcell platform could reconstitute the immune system in 100 days instead of the 12 to 18 months observed in physiology, thereby protecting patients from infection and relapse. SMART101 is produced by Smart Immune’s Contract Development and Manufacturing Organization partner in France, the MEARY Center for Cell and Gene Therapy at Paris St Louis Hospital (Assistance Publique - Hôpitaux de Paris, AP-HP).