REACT-01: Reversing Autoimmunity Through Cell Therapy

Launched by SEATTLE CHILDREN'S HOSPITAL · Jun 13, 2024

Keywords

ClinConnect Summary

The REACT-01 trial is a research study aimed at finding out if a new type of treatment can help children and young adults with Systemic Lupus Erythematosus (SLE) who have not responded well to existing therapies. In this study, doctors will collect a specific type of immune cell called T cells from participants' blood and then modify them in a lab to better target and destroy harmful B cells, which are part of the immune system that can cause problems in SLE. The goal is to see if this treatment is safe and effective for these patients.

To be eligible for the trial, participants must be between 2 and 30 years old and have SLE that hasn’t improved with standard treatments. They need to have stable health and not be pregnant or breastfeeding. Participants can expect to undergo a procedure to collect their T cells, stay near Seattle Children's Hospital for a month after treatment, and have regular follow-ups to monitor their health. This study is currently recruiting participants, and it's important for anyone considering joining to discuss it fully with their healthcare provider to understand the risks and benefits.

Gender

ALL

Eligibility 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