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NCT05600920 · ClinicalTrials.gov registry record · Phase 1
A Single-arm, Dose-escalation Trial of Long-acting Recombinant Human IL-7 (NT-I7, Efineptakin Alfa) for Idiopathic CD4 Lymphopenia
A Phase 1 study of Idiopathic CD4 Lymphopenia, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT05600920 is a Phase 1 study of Idiopathic CD4 Lymphopenia that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 60 participants. The trial reports 1 study location across 1 state.
The verdict
NCT05600920, a Phase 1 study of Idiopathic CD4 Lymphopenia, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Idiopathic CD4 lymphopenia (ICL) is a syndrome characterized by low levels of certain immune cells called CD4 T cells. The low CD4 T cells renders people with ICL prone to many types of severe infections, autoimmune diseases, and cancers. Although these infections and diseases can be treated whenever occur, there is currently no treatment that targeting the underlying deficiency of CD4 T cells can provide a definitive treatment for people with ICL. Objective: To test a new drug (NT-17) in people with ICL which can increase the number of CD4 T cells Eligibility: People aged 18 to 75 years with ICL who are also enrolled in NIH protocol 09-I-0102. Design: Participants will be screened. They will have a physical exam and blood tests. Some participants with high suspicion of central nervous system infection or history of such infections may also undergo a lumbar puncture. A thin needle will be inserted into their lower back to draw out a sample of the fluid around their spinal cord. Participants will receive 3 doses of NT-17, each about 12 weeks apart. NT-17 is injected into the muscle of the upper arm, thigh, or buttock. They will visit the clinic 5 days before each dose and again 2 and 4 weeks after each dose. Blood will be drawn at all visits. Participants will undergo leukapheresis 3 times. Blood will be drawn from a needle in one arm. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be given back through a second needle in the other arm. Some visits will include a rectal swab. Some participants may have additional tests, including a skin exam, skin biopsies, and medical imaging. Participants will have 3 follow-up visits every 3 months after they finish treatment.
Conditions Studied
Interventions
- DRUG Recombinant human interleukin (IL) 7-hyFc
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-11-06 |
| Est. Completion | 2026-11-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05600920
The ClinicalTrials.gov registry entry for NCT05600920 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Idiopathic CD4 Lymphopenia appearing as the primary indexed condition, and to 1 intervention - of which Recombinant human interleukin (IL) 7-hyFc is the first listed.
NCT05600920 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT05600920 about?
NCT05600920 is a clinical study titled "A Single-arm, Dose-escalation Trial of Long-acting Recombinant Human IL-7 (NT-I7, Efineptakin Alfa) for Idiopathic CD4 Lymphopenia". Background: Idiopathic CD4 lymphopenia (ICL) is a syndrome characterized by low levels of certain immune cells called CD4 T cells. The low CD4 T cells renders people with ICL prone to many types of severe infections, autoimmune diseases, and cancers. Although these infections and diseases can be tr...
What is the current status of trial NCT05600920?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2024-11-06. Estimated completion is 2026-11-01.
What conditions does trial NCT05600920 study?
This clinical trial studies the following conditions: Idiopathic CD4 Lymphopenia.
What interventions are being tested in trial NCT05600920?
The interventions under investigation include: Recombinant human interleukin (IL) 7-hyFc (DRUG).
Who is sponsoring clinical trial NCT05600920?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05600920 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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