Actively Recruiting

Phase 1
Age: 18Years - 70Years
All Genders
NCT04097561

Safety of Belimumab in People With Idiopathic CD4 Lymphopenia and Autoantibodies (Phoebe)

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-20

20

Participants Needed

1

Research Sites

375 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Background: People with Idiopathic CD4 lymphopenia (ICL) have lower numbers of a type of white blood cell called CD4 cells. White blood cells fight against infections. Low levels of CD4 cells may make a person more likely to get sick. There are no approved treatments for ICL. Researchers think a drug called belimumab may be able to help in specific situations. Objective: To see if belimumab is safe for people with ICL. Eligibility: People ages 18-70 who have ICL and are participating in NIH protocol 09-I-0102 (EPIC) Design: Participants will be screened with: Medical and medication history Physical exam Questionnaire about mental health and depression Blood and urine tests Participants will have a baseline visit. This will include some repeats of the screening tests. They may also have leukapheresis: Blood will be taken from a needle in one arm and passed through a machine that separates out the white blood cells. The rest of the blood will be returned through a needle in the other arm. Participants will receive 8 doses of belimumab through IV: A needle will insert a thin plastic tube into an arm vein. Belimumab will be given through the IV line. The first 3 doses will be given every 2 weeks. The other 5 will be given once every 4 weeks. Participants will have a physical exam and blood and urine tests at each dosing visit. They will be monitored for up to 4 hours after the infusion. Participants will have 3 follow-up visits, at around 8, 16, and 24 weeks after the last dose of belimumab. They will have a physical exam and blood and urine tests. Once they finish this protocol and they will continue to be followed under 09-I-0102 (EPIC study).

CONDITIONS

Official Title

Safety of Belimumab in People With Idiopathic CD4 Lymphopenia and Autoantibodies (Phoebe)

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 70 years
  • Enrolled in study 09-I-0102
  • Documented diagnosis of idiopathic CD4 lymphopenia with CD4 count below 300 cells/microliter on at least two occasions 6 weeks apart in the past and within the last 90 days
  • Positive for autoantibodies (e.g., ANA or antilymphocyte antibodies)
  • Female participants of childbearing potential must agree to use effective contraception from treatment start until 4 months after last dose
  • Able to provide informed consent
  • Willing to allow samples to be stored for future research
Not Eligible

You will not qualify if you...

  • Prior receipt of belimumab, except if previously enrolled in this study with up to 3 doses given and withdrawn for non-safety reasons, with at least 6 months since last dose
  • Allergy to any component of belimumab
  • HIV infection or other known immunodeficiency
  • Current moderate or severe acute illness or serious infection related to ICL unsuitable for study
  • Untreated hepatitis B or C
  • Active tuberculosis infection
  • Serum creatinine over 1.5 times normal
  • Hemoglobin below 8 g/dL
  • Elevated liver enzymes over twice normal
  • Serum IgG under 400 mg/L
  • Current use of systemic glucocorticosteroids (except nasal, inhaled, or topical steroids)
  • Recent cancer or autoimmune treatment affecting immune response within 6 months
  • Severe depression
  • Recent infections needing new medications within past 60 days
  • Receipt of vaccination within past 30 days
  • Pregnant or breastfeeding
  • Behavioral or substance use issues affecting study participation
  • Concomitant lupus is allowed if no cytotoxic or immunosuppressive medications and no history of unusual infections

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

I

Irini Sereti, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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