Smart Immune begins administering its ProTcell Therapy SMART101 to leukemia patients in the ReSET-02 Phase I/II study

Smart Immune, a biotech firm currently in the clinical phase and is progressing the ProTcell, a therapy platform to enhance the immune system empowered by thymus-derived T-cell progenitor, has proclaimed that the initial participants have started receiving doses in its ReSET-02 Phase I/II evaluation targeting adults diagnosed with acute leukemia and myelodysplastic syndromes.

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Two patients have been administered the initial dosage of SMART101, an allogeneic cell therapy created from donor mobilized peripheral blood stem cells which have been converted into T-cell progenitors utilizing the ProTcell treatment platform by Smart Immune. Preliminary results indicate that SMART101 is being well accepted, sporting a safety profile that matches the one observed in patients participating in the ongoing ReSET-01 clinical trial in the T-cell-depleted allogeneic HSCT scenario. Over the following weeks, more patients are projected to receive treatment, with a total of 40 planned enrollments.

The ReSET-02 trial is a public, multi-site Phase I/II analysis to examine the safety and efficacy of SMART101 post-standard-of care HSCT with following transplantation cyclophosphamide in adult patients suffering from hematological malignancies (acute lymphoid leukemia, acute myeloid leukemia, and myelodysplasia syndrome).

The trial aims to speed up T-cell reconstitution to combat relapse and infection, thereby enhancing overall and disease-free survival rates following transplantation. If the trial proves successful, it could fast-track the verification of ProTcell platform by Smart Immune, potentially finding use outside oncology, possibly in relation to HIV.

The European Medicines Agency along with the US FDA have approved SMART101 as an Orphan Drug, in addition to it receiving Fast Track Designation by the FDA, as a method to augment cell engraftment in patients undergoing HSCT. SMART101 is produced at the MEARY Center, AP-HP, situated in Paris. 

Sharing her thoughts, the CEO of Smart Immune, Karine Rossignol conveyed: “We are thrilled to initiate our trial to assess SMART101 in the standard-of-care haploidentical environment. Our objective lies in proving our capability to rapidly and completely reinforce the immune system to enhance survival statistics in cancers that are tough to cure, leveraging the thymus to offer a newfound immune system in a matter of a few months.”

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According to the data provided by the Synapse Database, As of October 3, 2023, there are 506 investigational drugs for the Acute Lymphoblastic Leukemia, including 189 targets, 464 R&D institutions involved, with related clinical trials reaching 3333，and as many as 41957 patents.

SMART-101 is a novel stem cell treatment medication with the possibility to treat a range of medical issues across the therapeutic domains of neoplasms, immune system disorders, congenital anomalies, endocrine and metabolic disorders, as well as hematologic and lymphatic diseases. The drug is currently under research for its efficacy in handling hematologic neoplasms, severe combined immunodeficiency, precursor B-lymphocyte lymphoblastic leukemia-lymphoma, acute lymphoblastic leukemia, and acute myeloid leukemia.