Actively Recruiting
Phase 12 Open-Label Trial of NT-I7 Efineptakin Alfa Injection to Boost CD4 T Cells in Adults with Idiopathic CD4 Lymphopenia
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-07-24
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
N
NeoImmuneTech
Collaborating Sponsor
AI-Summary
What this Trial Is About
Idiopathic CD4 lymphopenia ICL is a condition marked by low levels of CD4 T cells, which makes individuals vulnerable to severe infections, autoimmune diseases, and cancers. This trial evaluates a drug called NT-17 also known as efineptakin alfa or NT-I7 in adults aged 18 to 75 with ICL to assess its potential to increase CD4 T cell counts and study its safety. The trial is an open-label, single-arm, dose-escalation study conducted by the National Institute of Allergy and Infectious Diseases NIAID. Participants must also be enrolled in another NIH protocol related to ICL. Participants will receive three intramuscular doses of NT-17 spaced about 12 weeks apart, with dose levels based on body weight. The drug is administered in the upper arm, thigh, or buttock. Alongside dosing, participants undergo leukapheresis three times, where white blood cells are separated from their blood. Some visits may include rectal swabs, skin exams, biopsies, and imaging. Blood samples are collected before and after each dose to monitor immune cell levels and drug safety throughout the study. Participants will attend multiple clinic visits including screening, dosing visits, and follow-ups. Each dose visit includes blood draws before dosing and at 14 and 30 days after dosing. After completing treatment, participants have three follow-up visits every three months. The study measures adverse events and tracks changes in lymphocyte and immune cell counts up to 60 weeks. Quality of life questionnaires and safety monitoring are also part of participant involvement throughout the trial.
CONDITIONS
Brief Title
A Single-arm, Dose-escalation Trial of Long-acting Recombinant Human IL-7 (NT-I7, Efineptakin Alfa) for Idiopathic CD4 Lymphopenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years
- Able to provide informed consent
- Co-enrolled in NIH protocol 09-I-0102 related to idiopathic CD4 lymphopenia
- Documented ICL with CD4 T-cell count below 300 cells/microliter in at least two measurements at least 6 weeks apart
- Participants who can become pregnant or impregnate must agree to use two effective contraception methods, including one barrier method, from first pre-injection visit until 30 days after last injection, unless post-menopausal
You will not qualify if you...
- Current moderate or severe acute illness that makes participation unsuitable
- Active progressive cryptococcal CNS disease or nontuberculous mycobacterial infections within the last year
- Pregnant or breastfeeding
- HIV infection or other recognized immunodeficiency disorders
- Abnormal lab values including high creatinine, low platelets, low hemoglobin, elevated liver enzymes, or low immunoglobulin G
- Recent use of systemic steroids or immunomodulants
- Autoimmune diseases requiring systemic treatment except controlled vitiligo or endocrine diseases
- Recent malignancy requiring chemotherapy or immunotherapy
- Use of other investigational agents within 3 months
- Any condition deemed by the study team to contraindicate participation
Research Team
A
Andrea Lisco, M.D.
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