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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
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
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
CD4 Antigens
CD4 Antigens
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single CohortExperimental Treatment1 Intervention
Patients with ICL who are enrolled in 09-I-0102.
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.
Progressive multifocal leukoencephalopathy and anti-CD20 monoclonal antibodies: What do we know after 20 years of rituximab.
Progressive multifocal leukoencephalopathy and anti-CD20 monoclonal antibodies: What do we know after 20 years of rituximab.
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Who is running the clinical trial?
NeoImmune TechUNKNOWN
3 Previous Clinical Trials
192 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,311 Previous Clinical Trials
5,546,562 Total Patients Enrolled
1 Trials studying Idiopathic CD4 Lymphopenia
20 Patients Enrolled for Idiopathic CD4 Lymphopenia
Andrea Lisco, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
2 Previous Clinical Trials
950 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken systemic steroids or immune system drugs in the last 3 months, except for nasal sprays or inhalers and creams.I am between 18 and 75 years old.I have an autoimmune disease that needs treatment, but it's not vitiligo or a hormone issue treated with replacement.I have had a fungal or NTM infection in my brain or nervous system in the last year.I have HIV, chronic hepatitis B or C, or another immune deficiency.I need chemotherapy or immunotherapy for my cancer within 2 months.
Research Study Groups:
This trial has the following groups:- Group 1: Single Cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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