Phase 2 Lupus Trial, Recruiting NCT07053800 Sponsor: Autolus Limited Condition: Lupus
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Phase 2 Lupus Trial, Recruiting

NCT07053800
Recruiting Phase 2

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 willing and able to sign a consent form agreeing to take part (or have a legal guardian sign on your behalf)
  • You are able and willing to follow the trial's schedule of visits and requirements
  • You are between 12 and 65 years old (inclusive) at the time of signing the consent form
  • If you are female, you are not currently pregnant or breastfeeding
  • You have been diagnosed with Systemic Lupus Erythematosus (SLE, or lupus) based on recognised 2019 medical classification standards
  • A specific blood test has come back positive for at least one of the following markers linked to lupus: ANA, anti-dsDNA, or anti-Smith antibodies
  • Your lupus is currently severe and active, shown by a disease activity score of 8 or more points AND a kidney biopsy confirming a specific level of kidney involvement (Class III, IV, or a combination of Class V with III or IV) (confirm with trial site)
  • Your lupus has not responded well enough to previous treatments

Who may not be able to join:

  • You have ever previously received a specific type of treatment targeting CD19 cells (a type of immune cell)
  • You have had more than one serious lupus flare-up during the screening period that needed urgent treatment or made it impossible to stop certain medications beforehand
  • Your lupus has already caused serious, likely permanent damage to an organ (for example, complete kidney failure) to the point where the trial treatment is unlikely to help you, in the opinion of the trial doctor
  • You have a history of a condition called primary antiphospholipid antibody syndrome (a disorder affecting blood clotting) (confirm with trial site)
  • You currently have an active or uncontrolled fungal, bacterial, or viral infection
  • You have a history of cancer, unless you have been free of the disease for at least 24 months
  • You have had a transplant of the heart, lungs, kidneys, liver, or bone marrow/stem cells

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 28 July 2026
Phase 2: approximately ~30% 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

Phone: +44 (0)203 911 4385

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 2
Sponsor
Autolus Limited
Registry
ClinicalTrials.gov
Start date
16 January 2026
Est. completion
1 August 2028

Where this trial is recruiting

🇬🇷 Greece 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Proportion of participants who achieve complete renal response (CRR)

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: 28 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