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

NCT05600920 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-09

No results posted yet for this 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

  • Idiopathic CD4 Lymphopenia

Interventions

DRUG

Recombinant human interleukin (IL) 7-hyFc

Structural Formula: NT-I7 is a fusion protein comprising human IL-7 fused to the human IgD hinge region. This in turn is fused to the N-terminal region of CH2 from IgD and two key regions of the antibody IgG4: C-terminal region of CH2 and the entire CH3 region. NT-I7 will be administered by IM injection once every 12 weeks for a total of 3 doses, with the final dose at week 24. In the absence of treatment delays due to AEs, a treatment course of 24 weeks will be pursued in all enrolled participants. The dose levels to be used in this study are 240, 480, and 720 microgram/kg. NT-I7 dosing will be determined using the weight recorded at the screening visit. The dose will be based on the participant s actual body weight, unless the participant has a BMI \>=30 kg/m2, in which case adjusted body weight will be used.

Sponsors & Collaborators

  • NeoImmuneTech

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Andrea Lisco, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-06
Primary Completion
2026-11-01
Completion
2026-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05600920 on ClinicalTrials.gov