Phase 1 Lupus Trial, Recruiting NCT07331272 Sponsor: Nanjing Legend Biotech Co. Condition: Lupus
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Phase 1 Lupus Trial, Recruiting

NCT07331272
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:

  • People who are willing and able to give written consent to participate
  • People aged 18 to 70 years, of any sex
  • People whose organ function (such as liver and kidneys) meets the required health levels at screening
  • People who test positive for a protein called CD19 (a marker found on certain immune cells)
  • For the lupus (SLE) group: People who were diagnosed with SLE at least 6 months before the screening visit
  • For the lupus (SLE) group: People who test positive for certain immune markers in their blood (antinuclear antibody, anti-dsDNA antibody, and/or anti-Smith antibody) at screening
  • For the lupus (SLE) group: People whose SLE has come back after treatment or has not responded to previous treatments
  • For the muscle inflammation (IIM) group: People who were diagnosed with inflammatory muscle disease before the screening visit
  • For the muscle inflammation (IIM) group: People who test positive for certain antibodies related to muscle inflammation at screening
  • For the muscle inflammation (IIM) group: People whose muscle inflammation condition has come back after treatment or has not responded to previous treatments

Who may not be able to join:

  • People who have an active infection, such as hepatitis or tuberculosis
  • People who have other autoimmune diseases (besides the condition being studied)
  • People who have serious underlying health conditions, such as cancer or diabetes that is not well controlled
  • People who are currently pregnant or breastfeeding
  • People who have previously had a major organ transplant (such as a heart, liver, or kidney 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 21 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.

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Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Nanjing Legend Biotech Co.
Registry
ClinicalTrials.gov
Start date
29 January 2026
Est. completion
31 January 2028

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Incidence, severity, and type of treatment-emergent adverse events (TEAEs); Incidence of dose-limiting toxicity (DLT); Maximum concentration (Cmax) in peripheral blood; Time of maximum concentration (Tmax) in peripheral blood; Area under the concentration-time curve (AUC) in peripheral blood; Recommended Dose regimen finding

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: 21 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