Reversing autoimmunity in lupus using cell therapy
REACT-01: Reversing Autoimmunity Through Cell Therapy
This study is testing a new cell therapy to see if it can help young people with lupus who haven't responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 2 Years to 30 Years |
| Sex | All |
| Sponsor | Seattle Children's Hospital Academic / other |
| Drugs / interventions | Rituximab, Belimumab, Anifrolumab, CAR T, chimeric antigen receptor |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT06465147 on ClinicalTrials.gov |
What this trial studies
This phase 1, open-label study focuses on pediatric and young adult participants with treatment-refractory Systemic Lupus Erythematosus (SLE). The study aims to evaluate the safety, feasibility, and efficacy of genetically modified T cell products derived from peripheral blood mononuclear cells (PBMC) that express a CD19 specific chimeric antigen receptor (CAR). Participants will undergo apheresis to collect their T cells, which will then be bioengineered to target B cells involved in the autoimmune response. The study is designed to provide insights into a novel therapeutic approach for a challenging condition.
Who should consider this trial
Good fit: Ideal candidates are children and young adults aged 2-30 years with serologically active Systemic Lupus Erythematosus that has not responded to standard treatments.
Not a fit: Patients who are not refractory to treatment or who do not meet the specific eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for patients with refractory Systemic Lupus Erythematosus.
How similar studies have performed: While this approach is innovative, similar CAR T cell therapies have shown promise in other autoimmune conditions, suggesting potential for success in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female subjects aged between 2-30 years old. The first 3 subjects will be aged ≥ 17. The FDA will review safety data to determine if the age can be lowered first to ≥ 12 then, following the treatment of 3 further subjects aged 12-17, to ≥ 2 * Serologically active Systemic Lupus Erythematosus that is refractory to treatment * Able to tolerate apheresis or already has an apheresis product available for use in manufacturing. * ≥ 24 weeks post last Rituximab or related B cell depleting therapy * ≥ 12 weeks post last Belimumab / Anifrolumab therapy * ≥ 4 weeks post last calcineurin inhibitor treatment * For subjects receiving non-calcineurin immunosuppressive therapy, on a stable dose for ≥ 8 weeks before enrollment * For subjects receiving corticosteroid therapy, on a stable dose for ≥ 2 weeks before enrollment * Adequate organ function * Adequate laboratory values * Subjects of childbearing or child-fathering potential must agree to use highly effective contraception from consent through 12 months following infusion of investigational product on trial * Subjects must be willing to remain within 1 hour's drive of Seattle Children's Hospital for 4 weeks following CAR T cell infusion. * Subject and/or legally authorized representative has signed the informed consent form for this study Exclusion Criteria: * History or presence of active CNS lupus or other CNS disease * Kidney dysfunction requiring renal replacement therapy * Pregnant or breastfeeding * Insufficient pulmonary reserve including history of COPD, \>10 pack year smoking history or SLE lung disease with hypoxia at rest with oxygen saturation ≤92% on room air * Unable to tolerate repletion with any formulation of IgG. * Active or prior malignancy, unless the malignancy was treated and there is no evidence of recurrent disease \<5 years from enrollment. * Prior solid organ transplantation. * Presence of an active severe infection * Presence of any condition that, in the opinion of the investigator, would prohibit the subject from undergoing treatment under this protocol
Where this trial is running
Seattle, Washington
- Seattle Children's Hospital — Seattle, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Shaun Jackson, MD
- Email: Shaun.Jackson@seattlechildrens.org
- Phone: 206-987-3897
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.