Early Phase 1 Crohn's Disease and Colitis Trial, Recruiting NCT07435779 Sponsor: Hebei Senlang Biotechnology Inc., Ltd. Condition: Crohn's Disease and Colitis
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Early Phase 1 Crohn's Disease and Colitis Trial, Recruiting

NCT07435779
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:

  • The person wishing to participate, or their legal guardian, must be willing and able to give voluntary informed consent
  • People who have been diagnosed with ulcerative colitis (UC) according to specific Chinese medical guidelines from 2023, confirmed through a combination of clinical assessment, imaging, tissue samples, and camera examinations of the bowel, and who have been monitored for more than 3 months
  • People with moderate to severe active UC, measured using two specific scoring systems: a clinical score between 6 and 12, and a bowel camera (endoscopy) score of 2 or above, assessed within 10 days before the study start point
  • People whose UC has not responded to all currently approved UC medications in China, including standard immune-suppressing drugs, biologic therapies, and small molecule drugs
  • People whose blood counts, liver, kidney, heart, lung, and blood-clotting results meet specific health thresholds set by the trial (confirm with trial site)

Who may not be able to join:

  • People who are pregnant or currently breastfeeding
  • People whose overall health situation, in the treating doctor's judgement, could put them at greater risk or make it harder to interpret the trial's results
  • People diagnosed with Crohn's disease, indeterminate colitis, or other types of bowel inflammation that could affect how the trial results are assessed
  • People currently diagnosed with fulminant colitis (a severe, rapidly worsening form) and/or toxic megacolon (a serious complication causing the colon to dangerously expand)
  • People whose UC affects only the rectum
  • People who currently need, or are likely to need, a surgical opening in the abdomen to redirect the bowel (colostomy or ileostomy)
  • People who have previously had surgery to remove all or part of the colon and rectum
  • People who test positive for certain infections, including hepatitis B (under specific conditions), hepatitis C, HIV, cytomegalovirus (CMV), Epstein-Barr virus (EBV), or syphilis
  • People who have any active infection that is not under control at the time of signing the consent form
  • People who have had a serious, opportunistic, or ongoing/recurring infection outside the bowel within the 2 months before screening, an active shingles (herpes zoster) infection within 8 weeks before screening, or active or latent tuberculosis at the time of screening

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 8 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: Jianping Wang, Foresea Life Insurance Guangzhou General Hospital

Phone: 13763381162

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
Hebei Senlang Biotechnology Inc., Ltd.
Registry
ClinicalTrials.gov
Start date
4 February 2026
Est. completion
4 February 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Incidence of CRS and ICANS

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: 8 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