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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Autologous BCMA/CD19/CD19×BCMA-targeting CAR T cells, dosage 1\*10\^6/kg, intravenous injection once
Foresea Life Insurance Guangzhou General Hospital
Guangzhou, China
RECRUITINGIncidence 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
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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