Phase 2 Lupus Trial, Recruiting NCT06581198 Sponsor: Novartis Pharmaceuticals Condition: Lupus
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Phase 2 Lupus Trial, Recruiting

NCT06581198
Recruiting Phase 2 🇦🇺 Australian site

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:

  • Adults aged 18 to 75 years (inclusive) who have been diagnosed with Systemic Lupus Erythematosus (SLE, a chronic autoimmune disease) based on recognised international classification standards.
  • People whose blood tests show certain markers of lupus activity — specifically, a positive ANA test at a certain level, or raised levels of anti-dsDNA or anti-Sm antibodies, as measured by a central laboratory.
  • People who have active lupus affecting the kidneys (called lupus nephritis) without signs of significant long-term damage, or who have active lupus affecting other parts of the body.
  • People whose lupus activity score (called SLEDAI-2K) is 6 points or higher at the screening stage, not counting points related to fever, headache, hair loss, or certain brain-related symptoms.
  • People whose lupus has not responded well enough to at least two previous treatments.

Who may not be able to join:

  • People experiencing a sudden, severe lupus flare at the time of screening that requires immediate treatment beyond steroid injections, or that makes it impossible to safely stop current medications before the trial treatment.
  • People whose organs (such as the kidneys, liver, or heart) are not functioning well enough during the screening period.
  • People with a history of, or currently diagnosed with, heart rhythm or other heart problems that the trial team considers a significant safety risk.
  • People who test positive for HIV at the time of screening.
  • People who have an active or long-term hepatitis B or hepatitis C infection at the time of screening.
  • People who have had a serious blood clot event (grade 2 or higher) within the 4 weeks before screening.

Important: Other eligibility criteria set out in the trial protocol may also apply. 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: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Phone: 1-888-669-6682

Australian sites

Novartis Investigative Site, Clayton, Victoria

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
Registry
ClinicalTrials.gov
Start date
4 September 2024
Est. completion
14 February 2028

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇧🇷 Brazil 🇨🇿 Czechia 🇩🇰 Denmark 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇳🇱 Netherlands 🇳🇴 Norway 🇷🇴 Romania 🇸🇦 Saudi Arabia 🇸🇬 Singapore 🇰🇷 South Korea 🇪🇸 Spain 🇸🇪 Sweden 🇨🇭 Switzerland 🇹🇼 Taiwan 🇬🇧 United Kingdom 🇺🇸 United States

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Evaluate the efficacy of rapcabtagene autoleucel

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