[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"moderate-to-severe-ulcerative-colitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:moderate-to-severe-ulcerative-colitis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,63],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100651460","phase-1-a-trial-of-hrs-7085-tablets-in-patients-with-moderate-to-severe-active-ulcerative-colitis-100651460",false,"NCT07760831","A Trial of HRS-7085 Tablets in Patients With Moderate to Severe Active Ulcerative Colitis","A Phase IB Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HRS-7085 Tablets in Patients With Moderate to Severe Active Ulcerative Colitis","Inclusion Criteria:\n\n1. At least 18 years old and not more than 75 years old at the time of signing the Informed Consent Form (ICF), regardless of their sex.\n2. Body mass index \\[BMI = weight (kg)\u002Fheight2(m2)\\] ≥ 18 kg\u002Fm2 at screening.\n3. Participants with active UC who have a modified 9-point Mayo score of 5 to 9 and an endoscopic subscore of 2 to 3 at baseline (the interval between screening endoscopy and baseline cannot exceed 14 days), with a rectal bleeding subscore of at least 1.\n4. At the time of first dose, the participant is diagnosed with UC for at least 90 days, and UC is confirmed by investigation during the screening visit.\n5. The investigator considers that the participant has an inadequate response, loss of response, or intolerance to conventional therapy (oral 5-ASA, immunomodulators, or corticosteroids), anti-tumor necrosis factor (TNF) or other biologic therapy, JAK inhibitor therapy, or is unable to receive these treatments for other reasons.\n\n   Note: definitions of insufficient response, loss of response, or intolerance are provided in Appendix 13.5.\n6. If the participant is currently receiving the following UC therapy at screening, a stable dosage should be administered within the specified time:\n\n   1. Oral 5-ASA (mesalazine) (with stable dosage at least 2 weeks before baseline and during the study treatment period), AND\u002FOR\n   2. Oral corticosteroids (prednisone or prednisolone ≤ 20 mg\u002Fday) (with stable dosage for at least 2 weeks prior to baseline and during the treatment period). All other systemic corticosteroid routes are prohibited.\n7. The participant voluntarily signs the Informed Consent Form (ICF) before any study-related procedures, can communicate smoothly with the investigator, understands and is willing to strictly comply with the requirements of this clinical study protocol to complete the study.\n\nWomen of childbearing potential must agree to use highly effective contraceptive methods during the trial and within 3 months after the last dose of trial intervention. Serum or urine pregnancy tests must be negative before and during the trial. Females who are lactating are not eligible to participate in the trial (see Section 13.1 for details). Males must use highly effective contraceptive methods during the trial and within 3 months after the last dose of trial intervention during intercourse with a female of childbearing potential. Donation of sperm during this period is prohibited.\n\nExclusion Criteria:\n\n1. Any of the following medical histories or concomitant diseases:\n\n   1. Participants clinically diagnosed with unclassified colitis or suggestive of Crohn's disease.\n   2. Participants with UC, limited to proctitis (distal ≤15 cm).\n   3. Participants diagnosed with UC who are treatment-naive (no prior treatment received).\n   4. Participants presenting with clinical symptoms of ischemic colitis, fulminant colitis, or toxic megacolon.\n   5. Participants who have previously undergone surgery for UC or might require surgery during the study phase.\n   6. Screening investigation finds that the participant has a medical history of gastrointestinal dysplasia (atypical hyperplasia)\u002Fcancer or dysplasia (atypical hyperplasia)\u002Fcancer. Completely resected low-grade dysplasia will be excluded.\n   7. Participants with a positive Clostridium difficile (C. difficile) test at screening may be enrolled only if they have:\n\n      1. Completed appropriate standard-of-care treatment for C. difficile infection;\n      2. Achieved clinical resolution of diarrheal symptoms; AND\n      3. A documented negative repeat stool test (toxin A\u002FB assay or NAAT\u002FPCR) conducted after completion of treatment and within 7-14 days prior to baseline\u002Frandomization.\n   8. Participants with evidence of other intestinal infections within 30 days of endoscopic screening, or other intestinal pathogen screening.\n   9. The participant has or previously had:\n\n      1. Clinically significant infection (e.g., requiring hospitalization or parenteral antimicrobial therapy or opportunistic infection) within 1 month before baseline.\n      2. History of herpes zoster occurring twice or more, or herpes zoster disseminated (occurring once).\n      3. Any other infection history that the investigator considers might be aggravated by participation in this study.\n      4. Presence of any infection requiring antimicrobial therapy within 2 weeks before screening (excluding local antimicrobial therapy).\n2. Use of any of the following drugs or participation in clinical study (defined as signing the ICF and receiving at least one dose of drug or device therapy):\n\n   1. Received JAK inhibitors (upadacitinib, tofacitinib) within 4 weeks before baseline.\n   2. Received biological agents before baseline (for specific washout time, see Section 6.8.1):\n\n      1. Received anti-TNFα antibody therapy within 8 weeks before baseline;\n      2. Received anti-α4β7 antibody therapy within 12 weeks before baseline;\n      3. Received anti-interleukin (IL)-23 antibody therapy within 12 weeks before baseline.\n   3. Received treatment with azathioprine\u002F6-mercaptopurine, methotrexate, or thalidomide within 2 weeks before baseline.\n   4. Treatment with ciclosporin, mycophenolate mofetil, or tacrolimus within 4 weeks before baseline.\n   5. Received intravenous corticosteroids, or corticosteroids by rectal use, or 5-ASA by rectal use within 2 weeks before baseline.\n   6. Participation in any clinical study of drugs (including investigational vaccine) or medical devices within 3 months before baseline or within 5 half-lives of the investigational drug(s) (whichever is longer).\n3. Presence of the following important medical history or pre-existing diseases affecting safety:\n\n   1. The participant has a medical history of lymphoproliferative diseases, including lymphoma or symptoms and signs of potential lymphoproliferative disorders.\n   2. Participants with any active neoplasm malignant or history of neoplasm malignant within 5 years prior to the screening visit, except for recovered cutaneous squamous cell carcinoma or basal cell carcinoma or cervix carcinoma in situ.\n   3. Within 3 months prior to screening, participants with a medical history of moderate to severe cardiac failure congestive (New York Heart Association \\[NYHA\\] Grade 3 or above), occurrence of cardiovascular events or severe hemorrhage events, which the investigator considers unsuitable for the participant to participate in the clinical study.\n   4. Active tuberculosis (TB) or latent TB infection (defined as meeting at least one of the following criteria):\n\n      1. Presence of active TB or symptoms of active TB at screening.\n      2. A positive TB test (by QuantiFERON-TB Gold Test or other interferon-gamma release assay \\[IGRA\\]). If the IGRA result is indeterminate, a retest is allowed; participants within determinate results on both tests will be considered positive. For participants with a positive TB test but no clinical symptoms or imaging findings, prophylactic anti-TB treatment for at least 1 month is recommended before re-screening, and a positive result upon re-screening does not lead to exclusion criterion. For participants with a positive TB test but no clinical symptoms or imaging findings who have previously received prophylactic anti-TB treatment for at least 1 month, they should not be excluded based on this criterion;\n      3. Imaging examination within 3 months prior to screening indicating signs of active TB;\n      4. Participants with a medical history of active TB but with medical records proving completion of a full course of anti-TB treatment may confirm with the sponsor whether they could enter the study.\n   5. Hepatitis B Virus Surface Antigen (HBsAg), human immunodeficiency virus (HIV) antibody, syphilis antibody investigation, anti-Hepatitis C Virus (HCV) antibody test positive; if HBsAg-negative, but Hepatitis B core antibody (HBcAb)-positive and Hepatitis B Virus (HBV) DNA-positive or above the upper limit of normal (ULN).\n   6. Presence of severe, progressive, or uncontrolled diseases of the cardiovascular and cerebrovascular, hepatic, renal, pulmonary, gastrointestinal, hematopoietic, endocrine, nervous system (e.g., depression, suicidal tendency, and psychological disorders), or other conditions that the investigator considers inappropriate for the patient to participate in this trial.\n4. Screening:\n\n   1. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 3 × ULN.\n   2. Total bilirubin ≥ 1.5 × ULN.\n   3. Serum creatinine \\> 2.0 mg\u002FdL (177 μmol\u002FL).\n   4. Male participants with hemoglobin \\\u003C 85.0 g\u002FL, female participants \\\u003C 80.0 g\u002FL.\n   5. White blood cell count \\\u003C 3.0 × 10\\^9\u002FL.\n   6. Neutrophil count \\\u003C 1.5 × 10\\^9\u002FL.\n   7. Platelet count \\\u003C 100 × 10\\^9\u002FL.\n   8. 12-lead ECG investigation suggesting abnormalities with clinical significance that may affect the safety of the participant, including but not limited to acute myocardial ischemia myocardial infarction, severe arrhythmia or significant QTc prolongation. ECG exclusion criteria are detailed in Appendix 0.\n5. General conditions:\n\n   1. Pregnant or breastfeeding women (pregnancy is defined as the state after conception to the termination of gestation), or with a positive human chorionic gonadotropin (hCG) test result.\n   2. Allergy to the study drug or any component of the study drug.\n   3. A history of alcoholism or illegal drug abuse within 1 year prior to screening.\n   4. Received a live attenuated vaccine within 12 weeks before the first drug administration, or intends to receive a live attenuated vaccine during the study period, or participated in a vaccine clinical trial within 12 weeks before the first drug administration.\n   5. Donated approximately 500 mL or more of blood within 8 weeks prior to the first dose and\u002For plans to donate blood during the study period.\n\nThe investigator judges that there are circumstances affecting the evaluation of the safety and efficacy of the study drug.","ALL","18 Years","75 Years",{"count":20,"type":21},8,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The study is being conducted to evaluate the safety, tolerability and pharmakokinetics of HRS-7085 in adults.",[27],"Moderate to Severe Ulcerative Colitis","NOT_YET_RECRUITING","2026-08-07",{"date":31,"type":32},"2026-08-12","ACTUAL",{"date":34,"type":21},"2026-08",{"date":36,"type":21},"2027-09",{"name":38,"class":39},"Jiangsu HengRui Medicine Co., Ltd.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":59,"leadSponsor":61,"locationsCount":40},"100651166","phase-1-a-study-to-evaluate-the-safety-of-shr-7590-in-chinese-healthy-participants-and-in-patients-with-moderate-to-severe-ulcerative-colitis-100651166","NCT07758101","A Study to Evaluate the Safety of SHR-7590 in Chinese Healthy Participants and in Patients With Moderate-to-Severe Ulcerative Colitis","A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-7590 Via Subcutaneous or Intravenous Administration in Chinese Healthy Participants and Patients With Moderate-to-Severe Ulcerative Colitis","Inclusion Criteria:\n\n\\- Part 1\n\n* Voluntarily signed the informed consent form\n* Age from 18 to 55 years old\n* Body weight ≥45 kg, body mass index (BMI) 18-26 kg\u002Fm2\n* Normal or clinically insignificant vital signs, physical examination, laboratory examination and other examinations\n* Adopt efficient contraceptive measures\n\nExclusion Criteria:\n\n\\- Part 1\n\n* Suspected allergy to the study drug or any component of the study drug\n* Any clinical disease or any other disease that could interfere with the test results\n* Had a history of malignant tumor\n* Had an opportunistic infection within 6 months before screening\n* Acute infection with constitutional symptoms within 4 weeks before baseline\n* Participants who participated in any drug or device clinical trial within 3 months before screening\n* Use of any drug within 1 month before the use of the investigational drug\n* Patients who had used immunosuppressant or anti-interleukin antibody drugs within 6 months before screening\n* Had major trauma or major surgery within 6 months before screening, or were scheduled to undergo surgery during the trial\n* History of blood donation within 1 month before screening, or severe blood loss",true,"55 Years",{"count":51,"type":21},64,[24],"This Phase I first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SHR-7590 via subcutaneous or intravenous administration in Chinese healthy participants and patients with moderate-to-severe ulcerative colitis.",[27],"2026-08-05",{"date":57,"type":32},"2026-08-11",{"date":34,"type":21},{"date":60,"type":21},"2027-12",{"name":62,"class":39},"Guangdong Hengrui Pharmaceutical Co., Ltd",{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":40},"100616756","early-phase-1-universal-car-t-cell-injection-targeting-cd19bcma-in-patients-with-inflammatory-bowel-disease-100616756","NCT07309744","Universal CAR-T Cell Injection Targeting CD19\u002FBCMA in Patients With Inflammatory Bowel Disease","Clinical Study on Safety, Efficacy, and Pharmacokinetics of Universal CAR-T Cell Injection Targeting CD19\u002FBCMA in Patients With Inflammatory Bowel Disease","Inclusion Criteria:\n\n* The subject voluntarily participates in this trial and signs the informed consent form.\n* Aged ≥ 18 years and ≤ 70 years, regardless of gender.\n* Organ function and laboratory tests:\n\n  1. Liver function: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2 × Upper Limit of Normal (ULN); Total Bilirubin (TBIL) ≤ 2 × ULN (except for Gilbert's syndrome).\n  2. Renal function: Creatinine ≤ 1.5 × ULN or Creatinine Clearance ≥ 40 ml\u002Fmin.\n  3. Complete blood count: Neutrophil count ≥ 1 × 10⁹\u002FL; Hemoglobin ≥ 60 g\u002FL; Platelet count ≥ 20 × 10⁹\u002FL; Lymphocyte count \\> 0.3 × 10⁹\u002FL.\n  4. Coagulation function: International Normalized Ratio (INR) ≤ 1.5 × ULN, or Prothrombin Time (PT) ≤ 1.5 × ULN.\n  5. Oxygen saturation (SpO₂) ≥ 92% in room air at rest.\n  6. Echocardiography shows Left Ventricular Ejection Fraction (LVEF) ≥ 50%.\n* Female subjects of childbearing potential must have a negative result in serum or urine pregnancy test at screening.\n* Female subjects of childbearing potential must agree to use highly effective contraceptive methods from at least 28 days before the start of lymphodepletion until 12 months after RD06-05 infusion. Male subjects of childbearing potential must agree to use effective barrier contraceptive methods from the start of lymphodepletion until 12 months after RD06-05 infusion, and must not donate semen or sperm during the entire trial period.\n\nInclusion Criteria for Patients with Ulcerative Colitis (UC)\n\n* Diagnosis of ulcerative colitis confirmed by clinical and endoscopic evidence at least 3 months before screening, and verified by histopathological report. If no pathological report is available, additional biopsies may be performed during the screening period to obtain specimens, which will be sent to a local pathological laboratory for diagnostic confirmation.\n* Moderate to severe active ulcerative colitis, defined as a Mayo score between 6 and 12 points with an endoscopic subscore ≥ 2 points (endoscopic examination performed within 14 days before screening).\n* Confirmed that the extent of ulcerative colitis lesions involves above the rectosigmoid junction (approximately ≥ 15 cm from the anal verge).\n* Patients with extensive colitis or pancolitis with a disease duration of more than 8 years, or left-sided colitis with a disease duration of more than 12 years, must have written evidence of having undergone a colonoscopy within 12 months before the first screening visit (may be performed during the screening period or within 14 days before screening).\n* Subjects with a family history of colorectal cancer, personal history of high risk for colorectal cancer, age \\> 50 years, or other known risk factors must have completed colorectal cancer-related screening (including but not limited to colonoscopic biopsy, imaging, biomarkers, etc., which may be performed during the screening period).\n* Previous proven inadequate response, loss of response, or intolerance to at least one of the following drugs:\n\nGlucocorticoids:\n\nAfter at least one cycle of induction therapy (equivalent to oral prednisone 30 mg daily for 2 weeks or intravenous administration for 1 week), signs and symptoms of persistent active disease still exist; OR Previous failure of at least two attempts to reduce glucocorticoid dosage to below oral prednisone 10 mg\u002Fday or equivalent dose; OR Previous history of glucocorticoid intolerance (including but not limited to: Cushing's syndrome, osteopenia or osteoporosis, hyperglycemia, insomnia, infection, etc.).\n\nImmunomodulators:\n\nAfter previous treatment with oral azathioprine (≥ 1.5 mg\u002Fkg) or 6-mercaptopurine (≥ 0.75 mg\u002Fkg) for at least 8 weeks, signs and symptoms of persistent active disease still exist; OR Previous history of intolerance to at least one immunomodulator (including but not limited to: nausea, vomiting, abdominal pain, pancreatitis, abnormal liver function tests, lymphopenia, TPMT gene mutation, infection, etc.).\n\n* Patients with previous inadequate response, loss of efficacy, or intolerance to at least two drugs of different mechanism classes among biological therapy (such as anti-TNF antibodies, anti-IL antibodies, or anti-integrin antibodies) or Janus kinase (JAK) inhibitor therapy (such as upadacitinib) for ulcerative colitis. The aforementioned drugs must be domestically approved for the treatment of ulcerative colitis. Investigators must be able to provide relevant records of sufficient clinical treatment with the drug. Patients must meet any of the following criteria:\n\nInadequate efficacy: Despite induction therapy with the approved induction dose as specified in the drug instruction manual, the patient still shows signs and symptoms of persistent active disease; OR Loss of efficacy: On the basis of previous benefit, recurrence of signs and symptoms of active disease occurs during treatment with the approved maintenance dose as specified in the drug instruction manual (even if the drug is discontinued voluntarily after obtaining clinical benefit, it is not considered as biological therapy failure or intolerance to ulcerative colitis treatment); OR Intolerance: Previous history of intolerance to biological agents or JAK inhibitors approved for ulcerative colitis, including but not limited to infliximab, adalimumab, golimumab, ustekinumab, vedolizumab, upadacitinib, or others (including but not limited to infusion-related events, demyelination, congestive heart failure, or any drug-related adverse event leading to dose reduction or discontinuation).\n\n* The following drugs are allowed to be used in the study under stable dosage:\n\nOral 5-aminosalicylic acid (5-ASA) treatment: The prescribed dosage has been used stably for at least 2 weeks before the screening colonoscopy; Oral glucocorticoid treatment (prednisone ≤ 20 mg\u002Fday or equivalent dose, or extended-release budesonide tablets 9 mg\u002Fday): The prescribed dosage has been used stably for at least 2 weeks before the screening colonoscopy.\n\n* Having the condition to discontinue other therapeutic drugs for UC (except the above-mentioned allowed concomitant drugs) before pretreatment. For specific drugs, please refer to the \"Section 7.14 Prohibited Concomitant Treatments\" in the protocol and the corresponding drug washout period regulations.\n* Willing and able to complete the scheduled study assessments, including but not limited to endoscopic examinations.\n\nInclusion Criteria for Patients with Crohn's Disease (CD)\n\n* The subject must be diagnosed with Crohn's disease at least 3 months before enrollment, and the diagnosis must be confirmed by clinical, endoscopic, and histopathological criteria. If no pathological report is available, the investigator may obtain specimens through additional biopsies during the screening period and send them to a local pathological laboratory for diagnostic confirmation.\n* The subject must be a patient with moderate to severe active Crohn's disease, defined as a Crohn's Disease Activity Index (CDAI) score ≥ 220 points during the screening period, and meet any of the following conditions:\n\nElevated C-reactive protein (CRP) level during the screening period (based on the upper limit of the reference range of the laboratory of each study center); OR Colonoscopy within 4 months before screening shows at least 3 non-anastomotic ulcers (each with a diameter \\> 0.5 cm) or at least 10 aphthous ulcers (involving a continuous intestinal segment ≥ 10 cm), consistent with the characteristics of Crohn's disease; OR Computed Tomography Enterography (CTE), Magnetic Resonance Enterography (MRE), Contrast-Enhanced Small Bowel Radiography, or Capsule Endoscopy within 4 months before screening shows Crohn's disease-related ulcers (patients with only aphthous ulcers, fixed strictures, or small bowel strictures with pre-stenotic dilatation should not be enrolled).\n\n* Subjects with a family history of colorectal cancer, personal history of high risk for colorectal cancer, age \\> 50 years, or other known high-risk factors must complete the latest colorectal cancer monitoring (including but not limited to colonoscopy and endoscopic biopsy, imaging, tumor biomarkers, etc.).\n* The subject has inadequate efficacy, loss of efficacy, or poor tolerance to at least one of the following drugs:\n\nGlucocorticoids:\n\nGlucocorticoid-refractory disease: Refers to subjects who still have signs and\u002For symptoms of active Crohn's disease after receiving oral prednisone (or equivalent drug) at a daily dose of ≥ 30 mg or budesonide at a daily dose of ≥ 9 mg for at least 4 weeks; OR Glucocorticoid-dependent disease: Refers to (1) inability to reduce the dose to prednisone equivalent dose \\\u003C 10 mg\u002Fday or budesonide \\\u003C 3 mg\u002Fday within 3 months after starting glucocorticoid use; or (2) recurrence within 3 months after completing a course of glucocorticoid treatment; OR Glucocorticoid intolerance: Refers to adverse reactions that lead to drug discontinuation when the subject uses glucocorticoids, including but not limited to Cushing's syndrome, osteopenia\u002Fosteoporosis, hyperglycemia, neuropsychiatric adverse reactions, etc.\n\nImmunomodulators:\n\nPersistent signs and\u002For symptoms of active disease still exist after using any of the following drugs for at least 3 months:\n\n1. Oral azathioprine (AZA) at a daily dose of ≥ 1.5 mg\u002Fkg, or 6-mercaptopurine (6-MP) at a daily dose of ≥ 0.75 mg\u002Fkg, or methotrexate (MTX) at 25 mg per week (intramuscular injection or subcutaneous injection); OR\n2. Oral AZA or 6-MP within the therapeutic range determined by thiopurine metabolite detection; OR\n3. Combined use of thiopurine and allopurinol, and within the therapeutic range determined by thiopurine metabolite detection; OR Intolerance to at least one immunomodulator: Adverse reactions leading to drug discontinuation when using any immunomodulator, including but not limited to nausea\u002Fvomiting, abdominal pain, pancreatitis, abnormal liver function, lymphopenia.\n\n   * Subject with biological therapy failure: Refers to subjects with inadequate efficacy, loss of efficacy, or poor tolerance to at least two biological agents of different mechanisms that have been approved for the treatment of Crohn's disease (such as anti-TNF antibodies, anti-IL antibodies, or anti-integrin antibodies). Investigators must be able to provide sufficient medication history records during the induction period and\u002For maintenance period. The subject must meet one of the following criteria:\n\nInadequate efficacy: Refers to persistent signs and\u002For symptoms of active disease after induction therapy with the induction dose specified in the product instruction manual; OR Loss of efficacy: Refers to the recurrence of signs and\u002For symptoms of active disease after obtaining clinical improvement during treatment with the approved maintenance dose; OR Poor tolerance: Refers to adverse reactions that lead to dose reduction or discontinuation when the subject uses domestically or approved biological agents (including but not limited to infusion-related events, demyelination, congestive heart failure, etc.).\n\n* Subjects are allowed to use the following drugs concomitantly at a stable dose during the study:\n\nOral 5-aminosalicylic acid (5-ASA) treatment: The dose has been stable for at least 2 weeks before the screening colonoscopy; Oral glucocorticoid treatment (prednisone ≤ 20 mg\u002Fday or equivalent dose, or budesonide ≤ 9 mg\u002Fday): The dose has been stable for at least 2 weeks before the screening colonoscopy; Antibiotics specifically used for the treatment of Crohn's disease: If used continuously, the dose has been stable for at least 2 weeks before the screening colonoscopy; Probiotics: Such as Saccharomyces boulardii, etc., with a stable dose for at least 2 weeks before the screening colonoscopy; Antidiarrheals: Such as loperamide, compound diphenoxylate with atropine, etc., used to control chronic diarrhea.\n\n* Having the condition to discontinue other therapeutic drugs for CD (except the above-mentioned allowed concomitant drugs) before pretreatment. For specific drugs, please refer to the \"Section 7.14 Prohibited Concomitant Treatments\" in the protocol and the corresponding drug washout period regulations.\n* Willing and able to complete the planned study assessments, including endoscopic examinations and daily diary records.\n\nExclusion Criteria:\n\n* Presence of other coexisting autoimmune diseases that may significantly interfere with the attribution of study disease activity or pose additional safety risks. However, if the subject's condition has been clinically stable for ≥ 3 months and is not expected to interfere with study assessments, enrollment may be permitted after confirmation by the investigator and the sponsor's medical monitor (or their designee).\n\nSubjects with the following cardiac diseases will be excluded:\n\nHistory of heart failure classified as New York Heart Association (NYHA) Class III or IV.\n\nHistory of myocardial infarction, cardiovascular angioplasty or stenting, unstable angina, or other severe cardiac diseases within 12 months before enrollment.\n\nHistory of severe central nervous system (CNS) diseases that may affect the subject's ability to comply with the study protocol or interfere with the accuracy of study assessments, such as traumatic brain injury, disturbance of consciousness, epilepsy, cerebral ischemia, or cerebral hemorrhage.\n\nHistory of malignant tumors other than cured non-melanoma skin cancer or carcinoma in situ (e.g., carcinoma in situ of the cervix, bladder, or breast), unless the subject has been disease-free for at least 3 years.\n\nPrimary immunodeficiency. Presence of uncontrolled infection; simple urinary tract infections and upper respiratory tract infections are permitted as judged by the investigator and the sponsor's medical monitor (or their designee).\n\nKnown history of infection with human immunodeficiency virus (HIV), hepatitis C virus, or syphilis.\n\nActive or latent hepatitis B virus infection. Positive results for Epstein-Barr virus (EBV) or cytomegalovirus (CMV) DNA or IgM antibodies at screening.\n\nHistory of recurrent tuberculosis or known presence of recurrent tuberculosis. Subjects with a history of previous chimeric antigen receptor T-cell (CAR-T) therapy or any other genetically modified immune cell therapy will be excluded.\n\nAdministration of live-attenuated vaccines within 4 weeks before enrollment. History of allergy to any component of the cell therapy product. History of hypersensitivity to tacrolimus, or previous occurrence of ≥ Grade 3 tacrolimus-related toxicity (including but not limited to neurological, gastrointestinal, hepatic, renal, or hematological toxicity), especially subjects requiring hospitalization, will be excluded. Other cases may be considered eligible after confirmation by the investigator and the sponsor's medical monitor (or their designee).\n\nParticipation in another clinical trial within 30 days before screening. Pregnant or lactating subjects, as well as subjects of childbearing potential who cannot use effective contraceptive measures.\n\nConcomitant diseases requiring systemic treatment with therapeutic doses of glucocorticoids (except glucocorticoid treatment for adrenal insufficiency).\n\nPositive results for Clostridioides difficile (C. difficile) toxin or other intestinal pathogens detected within 30 days before colonoscopy screening or at screening. For subjects diagnosed with cytomegalovirus-associated colitis, adequate treatment must be completed and symptoms must be fully resolved for at least 3 months before the screening endoscopy.\n\nPatients with a history of lymphoma, leukemia, or any malignant tumor within the past 10 years are not allowed to enroll.\n\nThe following conditions do not exclude enrollment:\n\nBasal cell carcinoma or squamous cell carcinoma of the skin that has been adequately treated with no evidence of metastasis within 1 year; Carcinoma in situ of the cervix that has been adequately treated with no evidence of recurrence within 3 years before baseline.\n\nPatients with significant, uncontrolled neuropsychiatric diseases, patients judged by the investigator to be at risk of suicide, or patients with a history of alcohol dependence and\u002For substance abuse currently or within the past year are not allowed to enroll.\n\nPresence of unstable or uncontrolled diseases, including but not limited to cerebrocardiovascular, respiratory, gastrointestinal (excluding ulcerative colitis), hepatic, renal, endocrine, hematological, or neurological diseases, which may affect patient safety during the study or interfere with efficacy assessment.\n\nPatients with a known allergy to any component of the investigational drug are not allowed to enroll.\n\nAny other conditions deemed unsuitable for participation in the study by the investigator.","70 Years",{"count":72,"type":21},30,[74],"EARLY_PHASE1","This is an open-label, Phase I, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-05 in patients with moderate-to-severe ulcerative colitis (UC) and Crohn's disease (CD). The enrolled population consists of patients with refractory moderate-to-severe inflammatory bowel disease who have received multiple lines of biologic therapy.\n\nTwo cohorts are established in the study to explore the optimal biological dose (OBD) for each indication:\n\nCohort 1: Ulcerative Colitis Cohort Cohort 2: Crohn's Disease Cohort The study presets 3 dose groups, which are 3, 6, and 10×10⁶ CAR+T cells\u002Fkg respectively. The initial dose group is 3×10⁶ CAR+T cells\u002Fkg (Dose Group 1), and dose de-escalation or escalation may be conducted based on the assessment of the Safety Review Committee (SRC).\n\nIt is expected that no more than 9 patients will be enrolled in each cohort.",[77,78],"Moderate-to-severe Ulcerative Colitis","Crohn's Disease (CD)","2025-12-15",{"date":81,"type":32},"2025-12-30",{"date":83,"type":21},"2025-12-20",{"date":85,"type":21},"2028-12-30",{"name":87,"class":88},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER"]