NT-I7 for Idiopathic CD4 Lymphopenia
Trial Summary
What is the purpose of this trial?
This trial tests a new drug called NT-17 in people with idiopathic CD4 lymphopenia (ICL), a condition with low levels of important immune cells. The drug aims to increase these immune cells to help protect against infections and diseases. Participants will receive multiple doses of NT-17 and be monitored for safety and effectiveness.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using systemic glucocorticosteroids or immunomodulants (medications that affect the immune system) within 3 months of screening, except for certain types like nasal sprays or topical steroids.
What data supports the effectiveness of the drug NT-I7 for treating Idiopathic CD4 Lymphopenia?
Research shows that NT-I7, a form of interleukin-7, can increase the number of CD4 and CD8 T cells, which are important for immune function. This has been observed in studies involving healthy adults and HIV-infected patients, suggesting its potential to help people with low T-cell counts, like those with Idiopathic CD4 Lymphopenia.12345
Is NT-I7 safe for humans?
NT-I7, also known as hIL-7-hyFc, has been tested in humans and was generally well-tolerated, with the most common side effect being mild injection site reactions that resolved on their own. In studies with healthy volunteers and HIV-infected individuals, it showed a good safety profile, although some transient liver function changes and increases in HIV-RNA levels were noted in a few cases.14567
How is the drug NT-I7 different from other treatments for Idiopathic CD4 Lymphopenia?
NT-I7 is unique because it is a long-acting form of interleukin-7 (IL-7) fused with a hybrid Fc, which helps increase T-cell counts and improve immune function. Unlike other treatments, it is specifically designed to enhance T-cell proliferation and persistence, making it a promising option for patients with compromised T-cell immunity.15689
Research Team
Andrea Lisco, M.D.
Principal Investigator
National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria
Adults aged 18-75 with Idiopathic CD4 Lymphopenia (ICL), a condition where they have dangerously low levels of certain immune cells, can join this trial. They must be part of another NIH study and not pregnant or breastfeeding. People with HIV, hepatitis B/C, other immunodeficiencies, recent cancer treatments, severe illnesses, or using certain medications are excluded.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 3 doses of NT-I7, each about 12 weeks apart, with blood drawn at each dose visit and additional tests conducted
Follow-up
Participants are monitored for safety and effectiveness after treatment, with 3 follow-up visits every 3 months
End-of-study evaluation
Final study visit to evaluate the number and severity of adverse events and immunologic effects
Treatment Details
Interventions
- Recombinant human interleukin (IL) 7-hyFc (Cytokine)
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
NeoImmuneTech
Industry Sponsor
NeoImmune Tech
Collaborator