NT-I7 for Idiopathic CD4 Lymphopenia

A Single-arm, Dose-escalation Trial of Long-acting Recombinant Human IL-7 (NT-I7, Efineptakin Alfa) for Idiopathic CD4 Lymphopenia

Recruiting Phase 1 Phase 2 Interventional Study
Idiopathic CD4 Lymphopenia
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) · NIH
Who this trial is looking for

This trial is looking for adults aged 18 to 75 with a specific immune condition called Idiopathic CD4 Lymphopenia. Participants will receive three doses of a new drug that aims to increase a type of immune cell, along with regular visits for health checks and tests.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am between 18 and 75 years old
  • I can give my consent to participate
  • I am enrolled in another related study
  • I have been diagnosed with Idiopathic CD4 Lymphopenia
  • I am able to use effective contraception if needed

You may not be able to join if

  • I have a serious illness that makes me unfit for the study
  • I have active infections in my central nervous system
  • I am pregnant or breastfeeding
  • I have HIV or other severe immune deficiencies
  • I have kidney or blood issues beyond certain limits
  • I have taken steroids or similar treatments recently
  • I have a serious autoimmune disease
  • I have had certain cancers recently

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 CD…
Trial Locations
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Eligibility Criteria
* INCLUSION CRITERIA: Individuals must meet all of the following criteria to be eligible for study participation: 1. Aged 18 to 75 years. 2. Able to provide informed consent. 3. Co-enrolled in NIH protocol 09-I-0102, Etiology, Pathogenesis, and Natural History of Idiopathic CD4+ Lymphocytopenia (E…
Contacts

Andrea Lisco, M.D.

(301) 761-7122

andrea.lisco@nih.gov

CONTACT