Smart Immune treats adult acute leukemia patient at final dose level in Phase I/II ReSET-02 trial
02 May 2024 - 11:00AM
Smart Immune treats adult acute leukemia
patient at final dose level in Phase I/II
ReSET-02 trial
PARIS, France, May 2, 2024 –
Smart Immune, a clinical-stage biotechnology company developing
ProTcell, a thymus-empowered T cell progenitor therapy platform to
rapidly re-arm the immune system against cancers and infections,
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.
About Smart Immune
Smart Immune is a clinical-stage biotechnology
company developing ProTcell, a thymus-empowered T cell progenitor
platform to rapidly re-arm the immune system against cancer and
infection. The company aims to radically improve outcomes for
patients in hematology and immuno-oncology. SMART101 is in Phase
I/II trials for patients with acute leukemia or severe combined
immunodeficiencies (SCID), in the EU and the US. Additional
clinical applications are planned to be evaluated in combination
with innovative cancer therapies.
https://www.smart-immune.com/LinkedIn | X (formerly Twitter)
About the ReSET-02 clinical
trial
SMART101 is being evaluated in the ReSET-02
Phase I/II multi-center, open-label, dose-escalation study (1.5 x
106 CD7+ cells per kg of body weight, 4.5 x 106 CD7+ cells and 9.0
x 106 CD7+ cells per kg of body weight) to evaluate the safety and
activity of SMART101 after haploidentical peripheral blood stem
cell transplantation with post-transplant cyclophosphamide, in
patients with hematological malignancies. In the Phase II segment,
patients are being enrolled in parallel into two cohorts according
to the intensity of the conditioning chemotherapy and in two
consecutive stages according to a Simon’s 2-stage design. The trial
is currently conducted at multiple sites in France and Italy. For
more information, visit www.clinicaltrials.gov, study identifier
number NCT05768035.
About SMART101
SMART101 is generated ex vivo in 7
days from allogeneic blood stem 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.
Media contact:
ICR
Consiliumsmartimmune@consilium-comms.com