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news.Cellerant Therapeutics has initiated a Phase I/II clinical trial of CLT-008 in patients receiving intensive post-remission chemotherapy for high-risk leukemia or myelodysplasia.
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The open-label, multi-centre, dose escalation trial will assess the safety and tolerability of CLT-008 in the setting of chemotherapy-induced neutropenia.
The trial will enroll approximately 30 evaluable patients with high-risk acute myelogenous leukemia, acute lymphoblastic leukemia (ALL/AML), chronic myelogenous leukemia (CML) or myelodysplasia (MDS).
The secondary objectives include efficacy-related endpoints such as time to neutrophil recovery, duration of severe neutropenia and thrombocytopenia, days of fever and incidence of infections and incidence and duration of hospitalisation.
CLT-008 is a first-in-class, allogeneic cell-based therapy, which is under development to provide hematopoietic support following high-dose chemotherapy or radiation exposure.
CLT-008 works by shortening the time to neutrophil recovery and decreasing the risks of febrile neutropenia and infection.
Cellerant is also developing CLT-008 for the treatment of Acute Radiation Syndrome (ARS) under a US Government contract.