Early Phase 1 Lupus Trial, Recruiting NCT06785519 Sponsor: He Huang Condition: Lupus
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Early Phase 1 Lupus Trial, Recruiting

NCT06785519
Recruiting Early 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 18 years of age or older
  • You have been diagnosed with systemic lupus erythematosus (SLE, a type of autoimmune disease) and have a specific form of kidney disease related to lupus (called lupus nephritis, Grade III, IV, or V), confirmed by a kidney biopsy
  • Your lupus disease activity scored at least 8 on a standard measurement scale (called SLEDAI-2K) at your screening visit (confirm with trial site)
  • Your lupus has not responded to at least two standard treatments, or your condition has come back after previous treatment
  • You are expected to live for more than 12 weeks
  • If you are able to have children (whether male or female), you agree to use appropriate birth control before, during, and for 6 months after receiving the treatment, as its effects on unborn children are not yet known
  • You are willing to take part in the trial and have signed a consent form

Who may not be able to join:

  • You have a history of serious brain or head injury, loss of consciousness, epilepsy (seizures), or stroke
  • You have or have had a serious heart condition, such as a significantly abnormal heart rhythm or a prolonged QT interval shown on a heart tracing (ECG)
  • You currently have an active infection that has not been treated or cleared
  • You currently have an active hepatitis B or hepatitis C infection
  • You have taken more than 20mg per day of prednisone or a similar steroid medication in the week before starting treatment (not including inhaled steroids)
  • You have previously received any gene therapy products
  • Your immune cells do not respond well enough to a specific laboratory test used to prepare the treatment (confirm with trial site)
  • Your liver test results are significantly above the normal range (confirm with trial site)
  • You have another serious uncontrolled health condition that the trial team considers makes participation unsafe
  • You are infected with HIV
  • There is any other reason the trial team believes your participation could be unsafe or could affect the trial results

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
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Principal Investigator: He Huang, MD, Zhejiang University

Phone: 0571-87233772

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
Early Phase 1
Sponsor
He Huang
Registry
ClinicalTrials.gov
Start date
31 January 2025
Est. completion
31 October 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Dose-limiting toxicity (DLT); Incidence of treatment-emergent adverse events (TEAEs)

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