An Early Phase 1 interventional study of BCMA CAR-T or CD19 CAR-T or CD19×BCMA in UC, sponsored by Hebei Senlang Biotechnology Inc., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Hebei Senlang Biotechnology Inc., Ltd. · Early Phase 1, Interventional, and Treatment
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.
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.
Hebei Senlang Biotechnology Inc., Ltd. is the lead sponsor of 40 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Also known as: Biological: BCMA/CD19/CD19×BCMA CAR-T
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.
Time frame: 28 days
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.
Time frame: 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.
Time frame: 1 year
Endoscopic mucosal healing rate: 12 weeks and 52 weeks
No ulcers are observed on endoscopy.
Time frame: 1 year
Endoscopic response rate: 12 weeks and 52 weeks
Endoscopic remission: ES = 0.
Time frame: 1 year
IBDQ score assessment
IBDQ score.
Time frame: 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.
Time frame: 1 year
level of IL-6
Pharmacodynamics data parameter
Time frame: 1 year
Pharmacodynamics data parameter
CRP
Time frame: 1 year
Ferritin level
Pharmacodynamics data parameters
Time frame: 1 year
Ultrasound response rate: 12 weeks and 52 weeks
Ultrasound response: Reduction in bowel wall thickness (BWT) compared to baseline
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 1year
Started Feb 2026 (actual). Primary completion is estimated for Feb 2027, 12 months after the start.
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