Safety of Belimumab in People With Idiopathic CD4 Lymphopenia and Autoantibodies (Phoebe) (NCT04097561) | Clinical Trial Compass
RecruitingPhase 1
Safety of Belimumab in People With Idiopathic CD4 Lymphopenia and Autoantibodies (Phoebe)
United States20 participantsStarted 2020-01-13
Plain-language summary
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).
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
Individuals must meet all of the following criteria to be eligible for study participation:
* Aged 18-70 years.
* Enrolled in study 09-I-0102.
* Has a documented diagnosis of ICL, defined as the following:
* CD4 count \< 300 cells/microliter in at least 2 separate measurements 6 weeks apart at any point in the past, AND
* CD4 count \< 300 cells/microliter within previous 90 days.
* Evidence for autoantibody positivity (eg, ANA or in the research flow method looking for antilymphocyte antibodies).
* Female participants of childbearing potential must agree to use adequate contraception when engaging in sexual activities that can result in pregnancy, beginning at day 0 (or day 30 for hormonal contraception) until 4 months after the last dose of belimumab.
Acceptable methods of contraception include the following:
* Hormonal contraception.
* Male or female condom.
* Diaphragm or cervical cap with a spermicide.
* Intrauterine device.
* Able to provide informed consent.
* Willing to allow samples to be stored for future research.
EXCLUSION CRITERIA:
Individuals meeting any of the following criteria will be excluded from study participation:
* Prior receipt of belimumab. Exception: If an individual had been previously enrolled in this study and received up to 3 doses of belimumab but had to withdraw for reasons that were not related to safety or clinical concerns, they may be re-enrolled. In this case, at least 6 months must have passed from th…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of adverse events (AEs) that are possibly, probably, or definitely related to belimumab.
Timeframe: Week 2 through Week 48
Trial details
NCT IDNCT04097561
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)