Autologous CAR-T cell treatment for refractory and relapsing ulcerative colitis

A Single-Center, Open-Label, Single-Arm Exploratory Clinical Study of Autologous CAR-T Cell Therapy Injection for the Treatment of Refractory and Relapsing Ulcerative Colitis

This study will try autologous CAR‑T cell injections to see if they can bring 12‑week clinical remission in people with moderate‑to‑severe ulcerative colitis who have not responded to approved treatments.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Hebei Senlang Biotechnology Inc., Ltd. (Industry-sponsored)
• Drugs / interventions: CAR-T
• Locations: 1 site (Guangzhou)
• Trial ID: NCT07435779 on ClinicalTrials.gov

What this trial studies

This is a single‑center, open‑label, single‑arm early‑phase study using patients' own (autologous) CAR‑T cells directed at BCMA, CD19, or a CD19×BCMA combination. Participants will undergo cell collection, manufacturing of a personalized CAR‑T product, and a single administration with clinical follow‑up to 52 weeks. The primary outcome is clinical remission at 12 weeks, with secondary outcomes including 12‑ and 52‑week clinical response rates, endoscopic and imaging measures of mucosal healing, quality of life, and safety monitoring. Eligibility requires moderate to severe active UC (modified Mayo 6–12, endoscopic score ≥2), failure of all approved domestic UC therapies, and adequate organ and hematologic function.

Who should consider this trial

Good fit: Ideal candidates are people with moderate‑to‑severe active ulcerative colitis (modified Mayo 6–12, endoscopic score ≥2), a disease history >3 months, documented failure of all approved UC medications, and sufficient organ and blood‑test results who can give informed consent.

Not a fit: People who are pregnant or breastfeeding, have only mild disease, are still responding to standard therapies, or have medical contraindications to cell therapy are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this approach could provide a new option to induce clinical and endoscopic remission for patients with UC who have failed conventional, biologic, and small‑molecule therapies.

How similar studies have performed: CAR‑T cell approaches for autoimmune diseases are early and mostly experimental; limited case reports and small cohorts in other autoimmune conditions show biologic activity but CAR‑T for ulcerative colitis is largely novel with little UC‑specific evidence.

Eligibility criteria

Inclusion Criteria:

* The subject or guardian must provide voluntary informed consent;
* Diagnosis based on the "Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (2023, Xi'an)": Patients diagnosed with UC (based on comprehensive evaluation including clinical, imaging, pathological, and endoscopic assessments), with a follow-up period of more than 3 months;
* Moderate to severe active ulcerative colitis: Patients meeting the criteria of a clinical modified Mayo score of 6-12 points and an endoscopic Mayo score (ES) ≥ 2 points (within 10 days prior to baseline);
* Previous treatments with all domestically approved medications for UC, including conventional immunosuppressive drugs, biologics, and small molecule drugs, have failed;
* Hematological, liver and kidney function, cardiopulmonary function, and coagulation function meet specific criteria.

Exclusion Criteria:

* Women who are pregnant or lactating;
* Any condition that, in the judgment of the Investigator, could increase the subject's risk or compromise the interpretation of the trial results;
* Diagnosed with CD (Crohn's Disease) or indeterminate colitis (IBD-unclassified), or other types of colitis or enteritis that may confound efficacy assessment;
* Currently diagnosed with fulminant colitis and/or toxic megacolon;
* UC limited to the rectum;
* Currently or likely to require colostomy or ileostomy;
* Has previously undergone total proctocolectomy or partial colectomy.
* Patients who test positive for hepatitis B surface antigen (HBsAg) should be excluded; if HBsAg is negative but hepatitis B core antibody (HBcAb) is positive, and peripheral blood HBV DNA is above the detection limit, they should be excluded; patients who test positive for hepatitis C virus (HCV) antibodies and HCV RNA should be excluded; patients who test positive for human immunodeficiency virus (HIV) antibodies; patients who test positive for cytomegalovirus (CMV) DNA; patients who test positive for Epstein-Barr virus (EBV) DNA; patients who test positive for both treponemal-specific antibodies and non-specific antibodies for syphilis should be excluded.
* Any uncontrolled active infection present at the time of signing the ICF.
* Subjects who have had severe, opportunistic, or chronic/recurrent extra-intestinal infections within 2 months prior to screening; evidence of active/infectious herpes zoster infection within 8 weeks prior to screening; active tuberculosis or latent tuberculosis infection present at screening.

Where this trial is running

Guangzhou

• Foresea Life Insurance Guangzhou General Hospital — Guangzhou, China (Recruiting)

Study contacts

• Principal investigator: Jianping Wang — Foresea Life Insurance Guangzhou General Hospital
• Study coordinator: Yingdi Chen

Conditions UC; UC；CAR-T