Phase 1 Lupus Trial, Recruiting NCT06465147 Sponsor: Seattle Children's Hospital Condition: Lupus
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Phase 1 Lupus Trial, Recruiting

NCT06465147
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 2 and 30 years old (note: the trial will start with people aged 17 and older, and may gradually open to younger ages after safety reviews)
  • You have Systemic Lupus Erythematosus (SLE/Lupus) that is still active in your blood and has not responded to other treatments
  • You are able to go through a blood-filtering process called apheresis, or a sample from this process is already available for making your treatment
  • It has been at least 24 weeks since your last treatment with Rituximab or a similar B-cell depleting drug
  • It has been at least 12 weeks since your last treatment with Belimumab or Anifrolumab
  • It has been at least 4 weeks since your last treatment with a type of medication called a calcineurin inhibitor
  • If you are taking certain other immune-suppressing medications, your dose has been stable for at least 8 weeks before joining
  • If you are taking steroid medications, your dose has been stable for at least 2 weeks before joining
  • Your organs (such as heart, liver, and kidneys) and blood test results are at an acceptable level (confirm with trial site)
  • You agree to use reliable birth control from the time of consent until 12 months after receiving the trial treatment
  • You are willing and able to stay within a 1-hour drive of Seattle Children's Hospital for 4 weeks after receiving the treatment
  • You (or your legal guardian) have signed the consent form agreeing to take part in this study

Who may not be able to join:

  • You have or have had active lupus affecting your brain or spinal cord, or another active condition affecting your nervous system
  • Your kidneys are not working well enough and you require dialysis or another kidney replacement therapy
  • You are currently pregnant or breastfeeding
  • You have significant lung problems, including a history of COPD, a smoking history of more than 10 pack-years, or lupus-related lung disease that causes low oxygen levels while at rest
  • You are unable to tolerate any form of immunoglobulin replacement therapy (a type of protein treatment given by infusion or injection)
  • You have or have had cancer, unless it was fully treated and there has been no sign of it returning for at least 5 years before joining the trial
  • You have previously received a solid organ transplant (such as a kidney, heart, or liver transplant)
  • You currently have a serious active infection
  • You have any other condition that the trial doctor believes would make it unsafe for you to participate (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Shaun Jackson, MD, Seattle Children's Hospital

Phone: 206-987-3897

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Seattle Children's Hospital
Registry
ClinicalTrials.gov
Start date
16 December 2024
Est. completion
1 October 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]; Rate of SCRI-CAR19v3 Manufacturing Success

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov