What side effects are associated with this type of intervention?

The most common treatments for Idiopathic CD4 Lymphopenia (ICL) that aim to increase CD4 T cell counts, such as NT-17, may include side effects like injection site reactions, flu-like symptoms, and potential immune system overactivation leading to autoimmune conditions. Other treatments for immune deficiencies often carry risks of infections, infusion reactions, and general immunosuppressive effects. It is important to monitor patients closely for these side effects during treatment.

What prior FDA approvals exist?

There are currently no FDA-approved treatments specifically targeting the underlying deficiency of CD4 T cells in Idiopathic CD4 Lymphopenia (ICL). The trial of NT-17 (Efineptakin Alfa) is investigating a novel approach to increase CD4 T cell counts in ICL patients, which is a unique strategy as existing treatments focus on managing infections and associated conditions rather than addressing the CD4 T cell deficiency itself.

What other types of research exist?

Currently, there are no specific alternatives to NT-17 mentioned for increasing CD4 T cell counts in Idiopathic CD4 Lymphopenia patients. However, exploring other immunomodulatory treatments, such as monoclonal antibodies targeting immune pathways or cytokine therapies, might provide potential alternatives. Consulting with a healthcare provider for the latest research and clinical trials in 2024 is recommended.

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Cytokine

NT-I7 for Idiopathic CD4 Lymphopenia

Phase 1 & 2

Recruiting

Led By Andrea Lisco, M.D.

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 60

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

The trial is testing NT-I7 (Efineptakin Alfa), a new drug designed to increase CD4 T cell counts in people with ICL. Participants will receive three doses via injection over several months and undergo regular blood tests, leukapheresis procedures to collect white blood cells, and possibly additional exams like lumbar punctures.

What are the potential side effects?

Potential side effects may include discomfort at the injection site, reactions related to the immune system's response such as fever or fatigue due to increased activity of white blood cells. More specific side effects will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 60

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 60

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 60 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number and severity of AEs possibly, probably, or definitely related to NT I7 administration evaluated at week 60 (end-of-study visit).

Secondary study objectives

CD4 Antigens

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single CohortExperimental Treatment1 Intervention

Patients with ICL who are enrolled in 09-I-0102.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Treatments for Idiopathic CD4 Lymphopenia (ICL) that aim to increase CD4 T cell counts, such as NT-17, work by enhancing the proliferation and survival of these crucial immune cells. NT-17 is a long-acting recombinant human IL-7, a cytokine essential for T cell development. By boosting CD4 T cell levels, these treatments address the core deficiency in ICL, potentially reducing the risk of severe infections, autoimmune diseases, and cancers, thereby improving patient outcomes.

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