Early Phase 1 Rheumatoid Arthritis Trial, Recruiting NCT06613490 Sponsor: The First Affiliated Hospital with Nanjing Medical University Condition: Rheumatoid Arthritis
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Early Phase 1 Rheumatoid Arthritis Trial, Recruiting

NCT06613490
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 willing to take part, can follow all the study steps, and have signed a consent form agreeing to participate.
  • You have been diagnosed with Rheumatoid Arthritis (RA) for at least 3 months, your RA is moderately to severely active, and previous treatments (such as disease-modifying or biologic drugs) have not worked well enough, stopped working, or caused side effects you couldn't tolerate.
  • You have been diagnosed with Antisynthetase Syndrome (ASyS) for at least 3 months and your condition is moderately to severely active (confirm with trial site).
  • You are between 18 and 70 years old (male or female).
  • Your doctors estimate you are expected to live for more than 12 weeks.
  • Your kidney function and liver enzyme levels (AST and ALT) are within acceptable ranges as measured by blood tests.
  • You have a general health/activity level score of 0–2 on a standard medical scale (meaning you are able to care for yourself and are not fully bedridden) (confirm with trial site).
  • An ultrasound of your heart shows it is working reasonably normally, with a pumping efficiency of at least 45%.
  • It has been at least 2 weeks since your last dose of hormonal, immune-suppressing, or other experimental treatment.

Who may not be able to join:

  • You have had a severe allergic reaction to, or cannot take, any of the trial medications: cyclophosphamide, fludarabine, or tozumab.
  • You have a genetic condition affecting your bone marrow, such as Fanconi syndrome, Kostmann syndrome, or Shwachman syndrome.
  • You currently have a serious active infection (bacterial, viral, or fungal) that requires strong intravenous antibiotics or is not under control.
  • You have been diagnosed with severe (Grade III or IV) heart failure.
  • You have a history of epilepsy or other serious brain or nervous system conditions.
  • You have had cancer in the past, unless it was a skin cancer or cervical cancer that has been fully cured, or a tumour that is no longer active (confirm with trial site).
  • You have significant bleeding problems, such as gastrointestinal bleeding or blood clotting disorders.
  • You have had unstable chest pain (angina), significant heart failure symptoms, or a heart attack in the last 6 months.
  • You are currently pregnant, breastfeeding, or planning to become pregnant within six months.
  • You have taken part in another clinical trial and received treatment within the last 3 months.

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
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

Phone: 086 18061202878

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
Registry
ClinicalTrials.gov
Start date
20 May 2025
Est. completion
20 October 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Incidence of 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: 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