Recruiting

HCT

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT07845942

Conditions

Refractory Systemic Juvenile Idiopathic Arthritis

Systemic Juvenile Idiopathic Arthritis

Systemic Juvenile Idiopathic Arthritis Associated Lung Disease

Eligibility Criteria

Sex: All

Age: 0 - 35

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The goal of this study is to collect clinical data and samples and to evaluate the feasibility of allogeneic hematopoietic cell transplantation (HCT) in children and young adults with refractory Systemic Juvenile Idiopathic Arthritis (sJIA), including those with sJIA-associated lung disease (sJIA-LD).

Conditions

Refractory Systemic Juvenile Idiopathic Arthritis

Systemic Juvenile Idiopathic Arthritis

Systemic Juvenile Idiopathic Arthritis Associated Lung Disease

Study ID

NCT07845942

Start date

Nov, 2026

Status verified date

Sep, 2026

Completion date

Jul, 2031

Anticipated

Primary completion date

Jul, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 35

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients <35 years of age are eligible, and participants must meet all the following criteria to be eligible for this study:
  • Diagnosis: Systemic Juvenile Idiopathic Arthritis (sJIA) diagnosed prior to age 16, fulfilling ILAR classification criteria for sJIA or the provisional PRINTO criteria for systemic arthritis. The diagnosis and disease course must be reviewed and confirmed by a pediatric rheumatologist.
  • Refractory Disease: sJIA that is refractory to standard therapy, defined as meeting at least one of these conditions despite appropriate treatment:
  • Persistent JIA activity: Ongoing active disease (e.g. uncontrolled arthritis or systemic features such as fever, rash, organ inflammation) or progressive joint damage or liver dysfunction that has not responded to biologic agents (IL-1/IL-6 inhibitors) and conventional therapies, or inability to wean from high-dose corticosteroids (steroid dependence).
  • Recurrent MAS: Two or more episodes of macrophage activation syndrome within a 2-year period, indicating a failure to control the hyperinflammation with medical management. (MAS is defined by clinical and laboratory criteria such as fever, cytopenias, hyperferritinemia, hemophagocytosis, etc., per standard definitions.)
  • sJIA-LD: Presence of lung disease related to sJIA, either symptomatic LD (e.g. chronic cough, tachypnea, hypoxemia) or progressive LD on imaging (worsening interstitial changes), meeting clinical/imaging features such as patchy ground-glass opacities, septal and pleural thickening, or clubbing of digits. sJIA-LD should be confirmed by a pulmonologist/radiologist (e.g. HRCT findings).

Exclusion Criteria:

  • Uncontrolled Infection: Presence of a severe, uncontrolled infection at time of enrollment (e.g. sepsis, pneumonia not responding to therapy).
  • Significant Organ Failure:
  • Cardiac: EF < 40%
  • Renal: GFR < 30 ml/hr
  • Active Malignancy: Concurrent cancer diagnosis or history of malignant disease requiring active treatment.
  • Pregnancy or Lactation: Female patients who are pregnant or breastfeeding. Female participants of childbearing potential must have a negative pregnancy test clinical result at screening (pregnancy testing is done as standard of care for all transplant patients).

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Overall Survival at 1 year [ Time Frame: 1-year post-transplant ]

Central Contacts and Locations

Central contacts

Sharat Chandra, MD

513-636-5917Sharat.Chandra@cchmc.org

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Sharat Chandra, MD

513-636-5917Sharat.Chandra@cchmc.org

Principal Investigator:

Sharat Chandra, MD

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Sep 29, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-30. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-09-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.