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NCT05600907 · ClinicalTrials.gov registry record · Early Phase 1
Study to Assess the Use of JSP191 in Matched Unrelated Donor Transplantation for Chronic Granulomatous Disease (CGD)
A Early Phase 1 study of Chronic Granulomatous Disease and CGD, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Active
- Registry status
- Early Phase 1
- Development phase
- 7
- Enrollment target
- 1
- Study location
NCT05600907: Active Early Phase 1 study of Chronic Granulomatous Disease and CGD, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT05600907 is a Early Phase 1 study of Chronic Granulomatous Disease and CGD that is active but no longer recruiting, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 7 participants, below the 32-participant average among 10 other Chronic Granulomatous Disease trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05600907, a Early Phase 1 study of Chronic Granulomatous Disease and CGD, is active but no longer recruiting, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 7 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Chronic granulomatous disease (CGD) is a rare immune disorder that can cause serious infections throughout the body. The only cure for CGD is a stem cell transplant. Transplants from a sibling are best, but many people must get transplants from unrelated donors. However, these transplants can cause serious complications in people with CGD. Objective: To see if a study drug (JSP191) can help improve the success rates of stem cell transplants for people with CGD from an unrelated donor. Eligibility: People aged 4 to 65 years with CGD who require a transplant. Design: Participants will be screened. Part of the screening will help to identify the best match to a transplant donor. Participants will have a physical exam, including dental and eye exams. They will have blood and urine tests. They will have tests of their breathing and heart function. A bone marrow sample will be taken. They will have their stem cells collected. Participants will have a catheter inserted into a vein in their chest. It will remain in place for the entire period of transplant and recovery. Participants will be in the hospital 40 to 50 days for the transplant. This will include a conditioning phase, to prepare their body for the procedure, as well as the transplant and recovery phases. As part of the conditioning phase, participants will receive JSP191 through a vein for 1 hour. After discharge, participants will have follow-up visits 2 times a week for 100 days. Additional follow-up visits will continue for 5 years....
Primary Outcome
To determine the engraftment rates, both early and long term, when using JSP191 in conjunction with TBI, Alemtuzumab and post transplant cyclophosphamide and sirolimus for unrelated donor transplantation of patients with Chronic Granulomatous Disease.
Conditions Studied
Interventions
- BIOLOGICAL JSP191
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2023-01-02 |
| Est. Completion | 2036-11-30 |
| Phase | Early Phase 1 |
What the registry record for NCT05600907 still lists
NCT05600907 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 32-participant average among 10 other Chronic Granulomatous Disease trials with a reported enrollment target (78% lower).
The record links to 2 conditions, with Chronic Granulomatous Disease appearing as the primary indexed condition, and to 1 intervention - of which JSP191 is the first listed.
NCT05600907 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05600907 about?
NCT05600907 is a clinical study titled "Study to Assess the Use of JSP191 in Matched Unrelated Donor Transplantation for Chronic Granulomatous Disease (CGD)". Background: Chronic granulomatous disease (CGD) is a rare immune disorder that can cause serious infections throughout the body. The only cure for CGD is a stem cell transplant. Transplants from a sibling are best, but many people must get transplants from unrelated donors. However, these transplan...
What is the current status of trial NCT05600907?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 7 participants. The study started on 2023-01-02. Estimated completion is 2036-11-30.
What conditions does trial NCT05600907 study?
This clinical trial studies the following conditions: Chronic Granulomatous Disease, CGD.
What interventions are being tested in trial NCT05600907?
The interventions under investigation include: JSP191 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05600907?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05600907 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Granulomatous Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05600907's enrollment target sits among peer trials
7 10th of 10 higher than 1 of 10 other Chronic Granulomatous Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Granulomatous Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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