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REACT-01: Reversing Autoimmunity Through Cell Therapy

Study Purpose

This is a phase 1, open-label, non-randomized study enrolling pediatric and young adult research participants with treatment-refractory Systemic Lupus Erythematosus (SLE), to examine the safety, feasibility, and efficacy of administering T cell products derived from peripheral blood mononuclear cells (PBMC) that have been genetically modified to express CD19 specific chimeric antigen receptor (CAR) A child or young adult meeting all eligibility criteria and meeting none of the exclusion criteria will have their T cells collected. The T cells will then be bioengineered into a CAR T cell that targets circulating and tissue residing B cells.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 2 Years - 30 Years
Gender All
More 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 remiain 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06465147
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Seattle Children's Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Shaun Jackson, MDColleen Annesley, MDCorinne Summers, MD
Principal Investigator Affiliation Seattle Children's HospitalSeattle Children's HospitalSeattle Children's Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Systemic Lupus Erythematosus
Arms & Interventions

Arms

Experimental: SCRI-CAR19v3

Single infusion of SCRI-CAR19v3

Interventions

Biological: - SCRI-CAR19v3

Single infusion of SCRI-CAR19v3

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Seattle Children's Hospital, Seattle, Washington

Status

Address

Seattle Children's Hospital

Seattle, Washington, 98105

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