Cytheris has initiated a phase I/IIa dose escalation study of patients suffering from idiopathic CD4 lymphocytopenia (ICL). Reportedly, the company’s trial is a further investigation of its investigative immunotherapy, CYT107 that is already the subject of six other studies for different indications.
The company has said that it is a phase I/IIa open-label, single arm clinical trial evaluating the safety profile of glycosylated recombinant human interleukin-7 (rhIL-7) as an immune modulator in patients with ICL at risk of disease progression. Secondary analyses will assess the immunostimulatory effects of rhIL-7 on T cell numbers and function.
According to Cytheris, the study population is aged over 18 years, with a confirmed diagnosis of ICL at risk for complications due to concurrent CD8 T cell lymphocytopenia and/or a history of opportunistic or otherwise serious infection, without autoimmunity or hematologic or lymphoid malignancy.
Approximately 35-40 patients are expected to be screened over a 3-year period to achieve the sample of 20 ICL patients. Reportedly, safety assessments of rhIL-7 will be the primary focus at each study visit, with secondary analyses of immune parameters, including changes from baseline in T cell numbers and function, at Weeks 24 and 48.
Therese Croughs, MD, chief medical officer of Cytheris, said: “ICL patients have a propensity to develop serious co-morbidities and the dearth of treatment options for their primary lymphocytopenia, particularly in patients who have experienced opportunistic or otherwise serious infections, means that the unmet medical need to establish novel immune treatments for ICL patients persists. IL-7 represents a promising investigative therapy which has shown in pre-clinical and Phase I studies in oncology and in HIV-infected patients to be well tolerated in repeated dose trials, with long-lasting increases in both CD4 and CD8 T cells.”
Reportedly, the study is sponsored, conducted and partially funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH. The ICICLE trial is designed to assess the safety and biological effects of repeated administration of CYT107 and will be conducted at the NIH Clinical Center in Bethesda, Maryland.