Phase 2 Lupus Trial, Recruiting NCT06121297 Sponsor: Cabaletta Bio Condition: Lupus
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Phase 2 Lupus Trial, Recruiting

NCT06121297
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 between 18 and 65 years old
  • You have been diagnosed with Systemic Lupus Erythematosus (SLE, or "lupus") based on recognised medical guidelines
  • A specific blood test (looking for certain antibodies linked to lupus) came back positive at the screening stage
  • If joining as a lupus kidney disease (lupus nephritis) participant: you have active lupus nephritis confirmed by a kidney biopsy, classified as a specific type (Class III or IV, with or without Class V) (confirm with trial site)
  • If joining as a non-kidney lupus participant: you have active lupus that is considered moderate to severe

Who may not be able to join:

  • You have a medical reason why a procedure to collect white blood cells from your blood (called leukapheresis) would not be safe for you
  • You have had a serious or life-threatening allergic reaction in the past to certain medicines called fludarabine or cyclophosphamide
  • You currently have an active infection that requires medical treatment
  • You have severe, worsening, or poorly controlled disease affecting the kidneys, liver, blood, gut, lungs, mental health, heart, or nervous system, including serious infections like blood poisoning
  • You have other health conditions that the trial doctor believes could put you at unacceptable risk, affect the trial results, or interfere with trial procedures
  • If applying as a lupus nephritis participant: you have kidney disease caused by something other than lupus
  • You have previously received a type of treatment called CAR T cell therapy
  • You have previously had a transplant of a solid organ (such as heart, liver, kidney, or lung) or a bone marrow/stem cell transplant

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

Principal Investigator: Medical Director, Cabaletta Bio

Phone: 267 759 3100

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
Cabaletta Bio
Registry
ClinicalTrials.gov
Start date
16 February 2024
Est. completion
1 December 2029

Where this trial is recruiting

🇨🇦 Canada 🇪🇸 Spain 🇺🇸 United States

Primary endpoints

To evaluate incidence of adverse events

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