Autologous CAR-T Cell Therapy for Refractory and Relapsing Ulcerative Colitis: A Single-Center Exploratory Study

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

A Single-Center, Open-Label, Single-Arm Exploratory Clinical Study on the Use of Autologous CAR-T Cell Therapy Injection for the Treatment of Refractory and Relapsing Ulcerative Colitis: A Preliminary Exploration of 12-Week Clinical Remission with Autologous CAR-T Cell Injection in Refractory and Relapsing Ulcerative Colitis.

Study Overview

• Status: Recruiting
• Conditions: UC
• Intervention / Treatment: Drug: BCMA CAR-T or CD19 CAR-T or CD19×BCMA

Detailed Description

The primary objective： Preliminary Exploration of 12-Week Clinical Remission with Autologous CAR-T Cell Injection for the Treatment of Refractory and Relapsing Ulcerative Colitis.

The secondary objectives： Evaluate the 12-Week and 52-Week Clinical Response Rates, Endoscopic Parameters (Endoscopic Response Rate, Endoscopic Remission Rate, Mucosal Healing), Ultrasound and Imaging (Response Rate, Remission Rate), Improvement in Quality of Life, and Safety of Autologous CAR-T Cell Therapy Injection for the Treatment of Refractory and Relapsing Ulcerative Colitis.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Yingdi Chen; Phone Number: 13763381162; Email: chenyd193@163.com

Study Locations

• China
  • Guangzhou, China
    • Recruiting
    • Foresea Life Insurance Guangzhou General Hospital
    • Contact: Yingdi Chen; Phone Number: 13763381162; Email: chenyd193@163.com
    • Sub-Investigator: Yingdi Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BCMA CAR-T or CD19 CAR-T or CD19×BCMA; Autologous BCMA/CD19/CD19×BCMA-targeting CAR T cells	Drug: BCMA CAR-T or CD19 CAR-T or CD19×BCMA; Autologous BCMA/CD19/CD19×BCMA-targeting CAR T cells, dosage 1*10^6/kg, intravenous injection once; Other Names: Biological: BCMA/CD19/CD19×BCMA CAR-T

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of CRS and ICANS	Evaluate the occurrence of cytokine release syndrome and severe neurotoxic adverse events within 28 days after CAR-T cell infusion.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical response rate: 12 weeks and 52 weeks	Clinical response (based on MMS): MMS decreases by ≥2 points and ≥30% from baseline, along with a reduction in RBS by ≥1 point or an RBS absolute value ≤1.	1 year
Clinical remission rate: 12 weeks and 52 weeks	Clinical remission (based on MMS): ES is 0 or 1, no fragility, RBS is 0, and SFS is 0 or 1 and not greater than baseline.	1 year
Endoscopic mucosal healing rate: 12 weeks and 52 weeks	No ulcers are observed on endoscopy.	1 year
Endoscopic response rate: 12 weeks and 52 weeks	Endoscopic remission: ES = 0.	1 year
IBDQ score assessment	IBDQ score.	1 year
Pharmacokinetic data parameters	Analysis using CAR DNA copy number measured by qPCR; the highest concentration of CAR-T cells expanded in peripheral blood after administration.	1 year
level of IL-6	Pharmacodynamics data parameter	1 year
Pharmacodynamics data parameter	CRP	1 year
Ferritin level	Pharmacodynamics data parameters	1 year
Ultrasound response rate: 12 weeks and 52 weeks	Ultrasound response: Reduction in bowel wall thickness (BWT) compared to baseline	1 year
Ultrasound remission rate: 12 weeks and 52 weeks	Ultrasound remission: Normal bowel wallthickness (small intestine <3mm, colon <4mm, with no complications detectable by this method	1 year
imaging response rate: 12 weeks and 52 weeks	Radiologic response (CTE/MRE): Improvement in bowel wall thickness, mesenteric inflammatory fat, bowel wall blood flow, and bowel wall enhancement signal compared to baseline, with perianal fistula-related VAlinf < 6.	1 year
imaging remission rate: 12 weeks and 52 weeks	Radiologic remission (CTE/MRE): Complete normalization of inflammatory parameters on bowel CTE or MRE, with perianal fistula-related VAlinf = 0.	1year

Collaborators and Investigators

• Sponsor: Hebei Senlang Biotechnology Inc., Ltd.
• Investigators: Principal Investigator: Jianping Wang, Foresea Life Insurance Guangzhou General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2026
• Primary Completion (Estimated): February 4, 2027
• Study Completion (Estimated): February 4, 2028

Study Registration Dates

• First Submitted: February 11, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: UC；CAR-T
• Other Study ID Numbers: S103IBD01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No