Smart Immune Receives IRB Approval For Phase 1/2 Clinical Trial of Proprietary Allogeneic T-cell Product Smart-101 (ProTcell™) for AML and ALL
PARIS, Oct. 13, 2021 (GLOBE NEWSWIRE) -- Smart Immune SAS, a T cell medicine company utilizing its proprietary ex-vivo biomimetic “thymus in a dish” technology to develop allogeneic T-cell progenitors Smart101 (ProTcell™) for rapid immune reconstitution, announced today that the institutional review board (IRB) of the Memorial Sloan Kettering Cancer Center (MSK) has approved the commencement of the Company’s phase 1/2 clinical trial. MSK will start enrolling patients in November, 2021.
The Smart-101 study protocol (ClinicalTrials.gov Identifier: NCT04959903) encompasses two experimental arms in adult and pediatric leukemia patients, respectively, and will enroll up to 36 patients. Study subjects chosen are AML/ALL patients who are eligible for allogeneic hematopoetic stem cell transplant (HSCT) and will receive their routine stem-cell transplant of CD34+ cells at first, and then Smart-101 at approximately day 7 after initial transplant. In all cases, Smart-101 ProTcells will be cultured from the same donor from whom the patient has received the initial CD34+ HSCT. This trial will rely upon a prospectively generated control database of AML/ALL patients who undergo routine HSCT’s at MSK. The principal investigator of this study is Dr. Jaap-Jan Boelens, MD, PhD at MSK.
“This is an important milestone for the Company as it represents the first ever clinical trial for any T-cell progenitor product in the U.S. From working quietly on this technology at the Necker Children’s Hospital in Paris for over a decade, to finally treating patients, I am proud of our journey and of the therapeutic versatility of these allogeneic T-cell progenitors that we have been able to reset rapidly a polyclonal T cell compartment to ultimately improve 1 year overall survival and non-relapses mortality,” said Dr. Marina Cavazzana, the physician co-founder of Smart-Immune. “As we treat very sick patients and hope to durably reconstitute their fragile immune systems, we plan to be cautious and measured in our development path-starting with first establishing unequivocal clinical proof of the efficacy and safety of our ProTcell™ that are devoid of any genetic engineering in this first phase of our development. Such proof can then pave the way for a more expedited clinical development of genetic engineered ProTcell™ in the future.”
The primary outcome measures of the trial are atday 100 post-HSCT and include (i) cumulative adverse events through day 100, (ii) T-cell reconstitution at day 100 measured as CD4+ counts and (iii) chronic and acute GvHD. Secondary outcomes of this trial include long-term endpoints such as (i) T-cell reconstitution through 24 months, (ii) cumulative infections through 24 months and (iii) non-relapse mortality through 24 months. One-year and two-year disease-free survival and overall survival will also be reported.
“Multiple publications have formally demonstrated that Early T cell reconstitution is essential for reducing Transplantation-related Mortality, which continues to be a clear medical need. Finding strategies to better predict and/or expedite early T cell reconstitution will make allogeneic-bone marrow transplantation safer and more effective. We are thrilled to initiate the SMART 101 trial, which aims to expedite early T cell reconstitution by early infusion of T cell progenitor (ProTcell™),” said Dr Jaap Jan Boelens, Chief of the Pediatric Stem Cell Transplantation and Cellular Therapies Service, MSK. This phase 1/2 marks the start of Smart-Immune’s extensive 5-year clinical trial plan launched with the support of its partners, ILIFE consulting for monitoring and project management and Venn Life sciences for Statistics and data management.
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