Idiopathic CD4 LymphopeniaPhase 1/2NCT05600920
A Single-arm, Dose-escalation Trial of Long-acting Recombinant Human IL-7 (NT-I7, Efineptakin Alfa) for Idiopathic CD4 Lymphopenia
A Phase 1/2 study testing Recombinant human interleukin (IL) 7-hyFc in people with Idiopathic CD4 Lymphopenia, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Idiopathic CD4 Lymphopenia
- What is being tested?
- Recombinant human interleukin (IL) 7-hyFc
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2024to 1 Nov 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals must meet all of the following criteria to be eligible for study participation:
- Aged 18 to 75 years.
- Able to provide informed consent.
- Co-enrolled in NIH protocol 09-I-0102, Etiology, Pathogenesis, and Natural History of Idiopathic CD4+ Lymphocytopenia (EPIC) study (NCT0086726).
- Documented ICL, defined as CD4 T-cell count <300 cells/microliter in at least 2 different measurements at least 6 weeks apart, at any point in the past.
- Participants who can become pregnant or who can impregnate their partner must agree to remain abstinent or to use 2 highly effective methods of contraception, at least 1 of which must be a barrier method, when engaging in sexual activities that can result in pregnancy, beginning at the first pre-injection visit until the 30 days after the last injection. Acceptable methods of contraception include the following:
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- Male or female condom.
- Diaphragm or cervical cap with a spermicide.
- Hormonal contraception.
- Intrauterine device.
- Note: Contraception requirements do not apply to participants who are post-menopause (age >=45 years plus no menses for 12 consecutive months without an alternative medical cause).
Who cannot join
- Individuals meeting any of the following criteria will be excluded from study participation:
- Current moderate or severe acute illness (eg, febrile illness, seizure, myocardial infarction, cerebrovascular accident, pulmonary embolism) that in the opinion of the study team would make the individual unsuitable for the study.
- Clinical or microbiologic evidence of active progressive cryptococcal central nervous system (CNS) disease or nontuberculous mycobacterial (NTM) infections within the last year. History of stable cryptococcal CNS disease or NTM diseases since more than 1 year can be enrolled but will need to have undetectable CSF cryptococcal antigen and initiate/maintain antifungal or antimycobacterial treatment, respectively.
- Pregnant or breastfeeding.
- HIV infection, chronic hepatitis B or C infection, and any other recognized congenital or acquired immunodeficiency (eg, SCID IL-2/JAK3/ADA, MAGT1, MHC1 deficiency, CVID, DOCK8).
- Serum creatinine >1.5 X ULN, platelets <50,000/microliter, hemoglobin <9 g/dL, AST/ALT>2.5 X ULN, total bilirubin >1.5 X ULN (except if due to Gilbert's syndrome), or immunoglobulin (Ig) G level <450 mg/L.
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- Current (within 3 months of screening) use of systemic glucocorticosteroids or immunomodulants other than corticosteroid nasal spray or inhaler and topical steroids.
- Any established diagnosis of autoimmune disease requiring systemic treatment except for vitiligo or endocrine disease (including diabetes, thyroid disease, and adrenal disease) controlled by replacement therapy.
- Malignancy requiring systemic chemotherapy or immunotherapy within 2 months of screening.
- Receipt of any other investigational agents within 3 months of screening.
- Any condition that, in the opinion of the study team contraindicates participation in this study.
- Participants will be selected in an equitable manner from the available pool of potentially eligible individuals, without regard to factors such as sex, gender, race, ethnicity, or socioeconomic status, except for age.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: An Open-Label, Single-Arm, Phase 1/2 Dose-Escalation Trial of Long-Acting Recombinant Human IL-7 (NT-I7, Efineptakin-Alpha) for Idiopathic CD4 Lymphopenia
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.
Read more
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.
Read the detailed description
Study Description:
Open-label trial of efineptakin alfa (NT-I7) to manage idiopathic CD4 lymphopenia (ICL). After baseline assessments, NT-I7 will be administered intramuscularly (IM) at the NIH Clinical Center (CC) once every 12 weeks for 3 total doses, with the final dose at week 24, in 3 cohorts of 10 participants each. The doses for each cohort are 240, 480, or 720 microgram/kg. Blood will be drawn at each dose visit, as well as 5 days before and 14 and 30 days after each dose visit. Blood laboratory evaluations will be performed at the NIH CC or by remote laboratory providers, with results shared with the NIH study team. Primary and secondary evaluations include assessment of adverse events (AEs) and T-cell counts. Questionnaires will be administered to assess patient health perceptions and quality of life. The final study visit will be at week 60.
Primary Objective:
Evaluate the safety (all AEs) of NT-I7 in patients with ICL.
Secondary Objective:
- Evaluate the immunologic effects of NT-I7 on peripheral CD4 T-cell counts in ICL patients.
- Evaluate the safety (study drug-related AEs) of NT-I7 in patients with ICL.
Exploratory Objectives:
- Evaluate the ability of NT-I7 to increase CD4 T-cell counts.
- Evaluate the clinical effects of NT-I7 administration in participants with treatment-refractory human papillomavirus (HPV)-related diseases.
- Evaluate the effect of NT-I7 on clinical sequelae, radiologic or laboratory findings associated with previous opportunistic infections.
- Evaluate effects of NT-I7 administration on presence/titer of clinical autoantibodies.
- Evaluate the immunogenicity of NT-I7.
- Evaluate the pharmacokinetics (PK) of NT-I7 and explore exposure-safety and exposure-efficacy relationships.
Primary Endpoint:
Number and severity of AEs observed after NT-I7 administration evaluated at week 60 (end-of-study visit).
Secondary Endpoints:
- Evaluation of the trajectory of absolute lymphocyte count (ALC), and CD4, CD8, B, and NK counts measured at all study visits up to week 60 (end-of-study visit).
- Evaluation of the trajectory of ALC and CD4, CD8, B, and NK counts measured at all study visits up to week 36 (interim analysis).
- Evaluation of the trajectory of ALC and CD4, CD8, B, and NK counts measured between week 36 (12 weeks after last dose of NT-I7) and week 60.
- Number and severity of AEs possibly, probably, or definitely related to NT-I7 administration evaluated at week 60 (end-of-study visit).
Exploratory Endpoints:
- Proportion of participants with CD4 T-cell counts >=300 cells/microliter with NT-I7 treatment evaluated at week 60 (end-of-study visit).
- Time (cumulative number of days or weeks) that participants with baseline CD4 T-cell counts <200 cells/microliter maintain CD4 T-cell counts >= 200 cells/microliter after initiating treatment with NT-I7.
- Changes in skin or mucosal manifestations of HPV diseases as evaluated by clinical photography, and dermatologic and histologic evaluation.
- Changes in the clinical, radiologic, or laboratory findings associated with previous history of opportunistic infections.
- Changes in presence and titer of clinical autoantibodies.
- Incidence of antidrug antibodies (ADA) to NT-I7 in the study population.
- Serum concentration of NT-I7 administered at specified timepoints for the maximum observed concentration (Cmax).
- Conditions
- Idiopathic CD4 Lymphopenia
- Being tested
- Recombinant human interleukin (IL) 7-hyFc
- Keywords
- Opportunistic Infections, Immunological Therapy, T-Cell Deficiency, Cytokine Therapy
- Medical subject headings
- T-Lymphocytopenia, Idiopathic CD4-Positive, Opportunistic Infections, Thymic aplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human interleukin (IL) 7-hyFcDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Cohort | Experimental | Patients with ICL who are enrolled in 09-I-0102. Receives: Drug: Recombinant human interleukin (IL) 7-hyFc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and severity of AEs possibly, probably, or definitely related to NT I7 administration evaluated at week 60 (end-of-study visit).
Evaluate the safety (all AEs) of NT-I7 in patients with ICL.
Measured: Week 60
Secondary outcomes (3)
Evaluation of the trajectory of ALC, and CD4, CD8, B, and NK counts measured at all study visits up to week 60 (end-of-study visit).
Evaluation of the immunologic effects of NT-I7 on peripheral CD4 T cell counts in ICL patients.
Measured: Up to Week 60
Evaluation of the trajectory of ALC and CD4, CD8, B, and NK counts measured at all study visits up to week 36 (interim analysis).
Evaluation of the immunologic effects of NT-I7 on peripheral CD4 T cell counts in ICL patients.
Measured: Up to Week 36
Evaluation of the trajectory of ALC and CD4, CD8, B, and NK counts measured between week 36 (12 weeks after last dose of NT-I7) and week 60.
Evaluation of the immunologic effects of NT-I7 on peripheral CD4 T cell counts in ICL patients.
Measured: Up to Week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start6 Nov 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic CD4 LymphopeniaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- NeoImmuneTech
- Responsible party
- Sponsor
- Investigators
- Andrea Lisco, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600920
- Sponsor's protocol ID
- 10000821
- Other IDs
- 000821-I
- Status last verified
- 13 Oct 2026
- First submitted
- 27 Oct 2022
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm, Phase 1/2 Dose-Escalation Trial of Long-Acting Recombinant Human IL-7 (NT-I7, Efineptakin-Alpha) for Idiopathic CD4 Lymphopenia
- ClinicalTrials.gov ID
- NCT05600920
- Acronym / sponsor ID
- 10000821
- Conditions
- Idiopathic CD4 Lymphopenia
- Keywords
- Opportunistic Infections, Immunological Therapy, T-Cell Deficiency, Cytokine Therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- NeoImmuneTech
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 1 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Description:
Open-label trial of efineptakin alfa (NT-I7) to manage idiopathic CD4 lymphopenia (ICL). After baseline assessments, NT-I7 will be administered intramuscularly (IM) at the NIH Clinical Center (CC) once every 12 weeks for 3 total doses, with the final dose at week 24, in 3 cohorts of 10 participants each. The doses for each cohort are 240, 480, or 720 microgram/kg. Blood will be drawn at each dose visit, as well as 5 days before and 14 and 30 days after each dose visit. Blood laboratory evaluations will be performed at the NIH CC or by remote laboratory providers, with results shared with the NIH study team. Primary and secondary evaluations include assessment of adverse events (AEs) and T-cell counts. Questionnaires will be administered to assess patient health perceptions and quality of life. The final study visit will be at week 60.
Primary Objective:
Evaluate the safety (all AEs) of NT-I7 in patients with ICL.
Secondary Objective:
- Evaluate the immunologic effects of NT-I7 on peripheral CD4 T-cell counts in ICL patients.
- Evaluate the safety (study drug-related AEs) of NT-I7 in patients with ICL.
Exploratory Objectives:
- Evaluate the ability of NT-I7 to increase CD4 T-cell counts.
- Evaluate the clinical effects of NT-I7 administration in participants with treatment-refractory human papillomavirus (HPV)-related diseases.
- Evaluate the effect of NT-I7 on clinical sequelae, radiologic or laboratory findings associated with previous opportunistic infections.
- Evaluate effects of NT-I7 administration on presence/titer of clinical autoantibodies.
- Evaluate the immunogenicity of NT-I7.
- Evaluate the pharmacokinetics (PK) of NT-I7 and explore exposure-safety and exposure-efficacy relationships.
Primary Endpoint:
Number and severity of AEs observed after NT-I7 administration evaluated at week 60 (end-of-study visit).
Secondary Endpoints:
- Evaluation of the trajectory of absolute lymphocyte count (ALC), and CD4, CD8, B, and NK counts measured at all study visits up to week 60 (end-of-study visit).
- Evaluation of the trajectory of ALC and CD4, CD8, B, and NK counts measured at all study visits up to week 36 (interim analysis).
- Evaluation of the trajectory of ALC and CD4, CD8, B, and NK counts measured between week 36 (12 weeks after last dose of NT-I7) and week 60.
- Number and severity of AEs possibly, probably, or definitely related to NT-I7 administration evaluated at week 60 (end-of-study visit).
Exploratory Endpoints:
- Proportion of participants with CD4 T-cell counts >=300 cells/microliter with NT-I7 treatment evaluated at week 60 (end-of-study visit).
- Time (cumulative number of days or weeks) that participants with baseline CD4 T-cell counts <200 cells/microliter maintain CD4 T-cell counts >= 200 cells/microliter after initiating treatment with NT-I7.
- Changes in skin or mucosal manifestations of HPV diseases as evaluated by clinical photography, and dermatologic and histologic evaluation.
- Changes in the clinical, radiologic, or laboratory findings associated with previous history of opportunistic infections.
- Changes in presence and titer of clinical autoantibodies.
- Incidence of antidrug antibodies (ADA) to NT-I7 in the study population.
- Serum concentration of NT-I7 administered at specified timepoints for the maximum observed concentration (Cmax).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Cohort | Experimental | Drug: Recombinant human interleukin (IL) 7-hyFcPatients with ICL who are enrolled in 09-I-0102. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Individuals must meet all of the following criteria to be eligible for study participation:
- Aged 18 to 75 years.
- Able to provide informed consent.
- Co-enrolled in NIH protocol 09-I-0102, Etiology, Pathogenesis, and Natural History of Idiopathic CD4+ Lymphocytopenia (EPIC) study (NCT0086726).
- Documented ICL, defined as CD4 T-cell count <300 cells/microliter in at least 2 different measurements at least 6 weeks apart, at any point in the past.
Key exclusion criteria (12 listed)
- Individuals meeting any of the following criteria will be excluded from study participation:
- Current moderate or severe acute illness (eg, febrile illness, seizure, myocardial infarction, cerebrovascular accident, pulmonary embolism) that in the opinion of the study team would make the individual unsuitable for the study.
- Clinical or microbiologic evidence of active progressive cryptococcal central nervous system (CNS) disease or nontuberculous mycobacterial (NTM) infections within the last year. History of stable cryptococcal CNS disease or NTM diseases since more than 1 year can be enrolled but will need to have undetectable CSF cryptococcal antigen and initiate/maintain antifungal or antimycobacterial treatment, respectively.
- Pregnant or breastfeeding.
- HIV infection, chronic hepatitis B or C infection, and any other recognized congenital or acquired immunodeficiency (eg, SCID IL-2/JAK3/ADA, MAGT1, MHC1 deficiency, CVID, DOCK8).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant human interleukin (IL) 7-hyFcStructural 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. | Drug | Single Cohort |
Primary outcome
Number and severity of AEs possibly, probably, or definitely related to NT I7 administration evaluated at week 60 (end-of-study visit).
Time frame: Week 60
Evaluate the safety (all AEs) of NT-I7 in patients with ICL.
3 secondary outcomes
Evaluation of the trajectory of ALC, and CD4, CD8, B, and NK counts measured at all study visits up to week 60 (end-of-study visit).
Time frame: Up to Week 60
Evaluation of the trajectory of ALC and CD4, CD8, B, and NK counts measured at all study visits up to week 36 (interim analysis).
Time frame: Up to Week 36
Evaluation of the trajectory of ALC and CD4, CD8, B, and NK counts measured between week 36 (12 weeks after last dose of NT-I7) and week 60.
Time frame: Up to Week 60
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea Lisco, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Recombinant human interleukin (IL) 7-hyFc in people with Idiopathic CD4 Lymphopenia, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Lisco, M.D. ((301) 761-7122, andrea.lisco@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and severity of AEs possibly, probably, or definitely related to NT I7 administration evaluated at week 60 (end-of-study visit). (time frame: Week 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.