UCEarly Phase 1NCT07435779
Autologous CAR-T Cell Therapy for Refractory and Relapsing Ulcerative Colitis: A Single-Center Exploratory Study
A Early Phase 1 study testing BCMA CAR-T or CD19 CAR-T or CD19×BCMA in people with UC, run by Hebei Senlang Biotechnology Inc., Ltd. at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- UC
- What is being tested?
- BCMA CAR-T or CD19 CAR-T or CD19×BCMA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 4 Feb 2026to 4 Feb 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Foresea Life Insurance Guangzhou General Hospital
Guangzhou
Yingdi Chen, 13763381162, chenyd193@163.com
Yingdi Chen
About this study
Official title: 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.
Read the 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.
- Conditions
- UC
- Being tested
- BCMA CAR-T or CD19 CAR-T or CD19×BCMA
- Keywords
- UC；CAR-T
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCMA CAR-T or CD19 CAR-T or CD19×BCMADrug
Also called Biological: BCMA/CD19/CD19×BCMA CAR-T
Autologous BCMA/CD19/CD19×BCMA-targeting CAR T cells, dosage 1*10^6/kg, intravenous injection once
| Study group | Role | What they receive |
|---|---|---|
| BCMA CAR-T or CD19 CAR-T or CD19×BCMA | Experimental | Autologous BCMA/CD19/CD19×BCMA-targeting CAR T cells Receives: Drug: BCMA CAR-T or CD19 CAR-T or CD19×BCMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (13)
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.
Measured: 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.
Measured: 1 year
Endoscopic mucosal healing rate: 12 weeks and 52 weeks
No ulcers are observed on endoscopy.
Measured: 1 year
Endoscopic response rate: 12 weeks and 52 weeks
Endoscopic remission: ES = 0.
Measured: 1 year
IBDQ score assessment
IBDQ score.
Measured: 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.
Measured: 1 year
level of IL-6
Pharmacodynamics data parameter
Measured: 1 year
Pharmacodynamics data parameter
CRP
Measured: 1 year
Ferritin level
Pharmacodynamics data parameters
Measured: 1 year
Ultrasound response rate: 12 weeks and 52 weeks
Ultrasound response: Reduction in bowel wall thickness (BWT) compared to baseline
Measured: 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
Measured: 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.
Measured: 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.
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start4 Feb 2026
- Primary completion4 Feb 2027 (estimated)
- Study completion4 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianping Wang, Principal investigator, Foresea Life Insurance Guangzhou General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435779
- Sponsor's protocol ID
- S103IBD01
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07435779
- Acronym / sponsor ID
- S103IBD01
- Conditions
- UC
- Keywords
- UC；CAR-T
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Feb 2026 (actual)
- Primary completion
- 4 Feb 2027 (estimated)
- Study completion
- 4 Feb 2028 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BCMA CAR-T or CD19 CAR-T or CD19×BCMA | Experimental | Drug: BCMA CAR-T or CD19 CAR-T or CD19×BCMAAutologous BCMA/CD19/CD19×BCMA-targeting CAR T cells |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCMA CAR-T or CD19 CAR-T or CD19×BCMAAlso: Biological: BCMA/CD19/CD19×BCMA CAR-TAutologous BCMA/CD19/CD19×BCMA-targeting CAR T cells, dosage 1*10^6/kg, intravenous injection once | Drug | BCMA CAR-T or CD19 CAR-T or CD19×BCMA |
Primary outcome
Incidence of CRS and ICANS
Time frame: 28 days
Evaluate the occurrence of cytokine release syndrome and severe neurotoxic adverse events within 28 days after CAR-T cell infusion.
13 secondary outcomes
Clinical response rate: 12 weeks and 52 weeks
Time frame: 1 year
Clinical remission rate: 12 weeks and 52 weeks
Time frame: 1 year
Endoscopic mucosal healing rate: 12 weeks and 52 weeks
Time frame: 1 year
Endoscopic response rate: 12 weeks and 52 weeks
Time frame: 1 year
IBDQ score assessment
Time frame: 1 year
Pharmacokinetic data parameters
Time frame: 1 year
level of IL-6
Time frame: 1 year
Pharmacodynamics data parameter
Time frame: 1 year
Ferritin level
Time frame: 1 year
Ultrasound response rate: 12 weeks and 52 weeks
Time frame: 1 year
Ultrasound remission rate: 12 weeks and 52 weeks
Time frame: 1 year
imaging response rate: 12 weeks and 52 weeks
Time frame: 1 year
imaging remission rate: 12 weeks and 52 weeks
Time frame: 1year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jianping Wang principal investigator
Foresea Life Insurance Guangzhou General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing BCMA CAR-T or CD19 CAR-T or CD19×BCMA in people with UC, run by Hebei Senlang Biotechnology Inc., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yingdi Chen (13763381162, chenyd193@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of CRS and ICANS (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.