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Universal CAR-T Cell Injection Targeting CD19/BCMA in Patients With Inflammatory Bowel Disease | Clinical Trials | Clareo Health

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Universal CAR-T Cell Injection Targeting CD19/BCMA in Patients With Inflammatory Bowel Disease

Clinical Study on Safety, Efficacy, and Pharmacokinetics of Universal CAR-T Cell Injection Targeting CD19/BCMA in Patients With Inflammatory Bowel Disease

NCT07309744•Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

View on ClinicalTrials.gov

Summary

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. Two cohorts are established in the study to explore the optimal biological dose (OBD) for each indication: Cohort 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/kg respectively. The initial dose group is 3×10⁶ CAR+T cells/kg (Dose Group 1), and dose de-escalation or escalation may be conducted based on the assessment of the Safety Review Committee (SRC). It is expected that no more than 9 patients will be enrolled in each cohort.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The subject voluntarily participates in this trial and signs the informed consent form.
•Aged ≥ 18 years and ≤ 70 years, regardless of gender.
•Organ function and laboratory tests:
•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).
•2. Renal function: Creatinine ≤ 1.5 × ULN or Creatinine Clearance ≥ 40 ml/min.
•3. Complete blood count: Neutrophil count ≥ 1 × 10⁹/L; Hemoglobin ≥ 60 g/L; Platelet count ≥ 20 × 10⁹/L; Lymphocyte count \> 0.3 × 10⁹/L.
•4. Coagulation function: International Normalized Ratio (INR) ≤ 1.5 × ULN, or Prothrombin Time (PT) ≤ 1.5 × ULN.
•5. Oxygen saturation (SpO₂) ≥ 92% in room air at rest.
•6. Echocardiography shows Left Ventricular Ejection Fraction (LVEF) ≥ 50%.
•Female subjects of childbearing potential must have a negative result in serum or urine pregnancy test at screening.
+35 more criteria

Exclusion Criteria

•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).
•Subjects with the following cardiac diseases will be excluded:
•History of heart failure classified as New York Heart Association (NYHA) Class III or IV.
•History of myocardial infarction, cardiovascular angioplasty or stenting, unstable angina, or other severe cardiac diseases within 12 months before enrollment.
•History 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.
•History 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.
•Primary 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).
•Known history of infection with human immunodeficiency virus (HIV), hepatitis C virus, or syphilis.
•Active or latent hepatitis B virus infection. Positive results for Epstein-Barr virus (EBV) or cytomegalovirus (CMV) DNA or IgM antibodies at screening.
•History 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.
+11 more criteria

Locations (1)

Union Hospital, Tongji Medical College, Huazhong Univerdity of Science and Technology

Wuhan, Hubei, China

Key Dates

Start Date

December 20, 2025

Primary Completion Date

December 30, 2027

Completion Date

December 30, 2028

Last Updated

December 30, 2025

Enrollment

ESTIMATED participants

Conditions

Moderate-to-severe Ulcerative ColitisCrohn's Disease (CD)

Interventions

RD06-05 CART Cell Infusion

DRUG

Contacts

Ruohang He, Attending Physician

CONTACT

027-85726057 1056610988@qq.com