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Cytokine
NT-I7 for Idiopathic CD4 Lymphopenia
Phase 1 & 2
Waitlist Available
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
Study Summary
This trial tests a new drug (NT-17) to increase the number of CD4 T cells in people with Idiopathic CD4 Lymphopenia (ICL), ages 18-75, enrolled in NIH protocol. Includes physical exams, blood tests, lumbar puncture & 3 doses of NT-17. Follow-up visits every 3 months.
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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number and severity of AEs possibly, probably, or definitely related to NT I7 administration evaluated at week 60 (end-of-study visit).
Secondary outcome measures
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.
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Who is running the clinical trial?
NeoImmune TechUNKNOWN
3 Previous Clinical Trials
182 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,268 Previous Clinical Trials
5,481,072 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What qualifications are necessary for individuals to register for this clinical research?
"This clinical trial is seeking 60 adults aged 18 to 75 that possess the cd4 antigen. Meeting these specific criteria is key for eligibility: providing informed consent, co-enrolled in related NIH protocol 09-I-0102 and NCT0086726 studies, male or female condoms usage, hormonal contraception methods, intrauterine device use, verified ICL (CD4 T cell count <300 cells/microliter with 2 measurements taken 6 weeks apart), diaphragm or cervical cap with a spermicide."
Answered by AI
Are there any opportunities to join this experiment as a participant?
"This research project, first posted on December 6th 2022, according to clinicaltrials.gov is no longer actively recruiting patients; however, there are presently six other medical studies that require enrolment."
Answered by AI
Does this research encompass individuals 45 or older?
"This study is seeking participants who are of legal age and under the age of 75."
Answered by AI
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