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

NCT07309744 | Not Yet Recruiting Early Phase 1

• 1 other identifier: BHCT-RD06-05-IBD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Moderate-to-severe Ulcerative Colitis; Crohn's Disease (CD)

Outcome Measures

Primary Outcomes (3)

• Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)

  From the day of cell infusion to 24 months after infusion

• Serious Adverse Events (SAEs)

  Time Frame: From the day of cell infusion to 24 months after infusion

• Adverse Events of Special Interest (AESIs)

  Time Frame: From the day of cell infusion to 24 months after infusion

Secondary Outcomes (7)

• Proportion of Patients Achieving Clinical Remission

  On the day of cell infusion, and at 28 days, 12 weeks, 24 weeks, 26 weeks, 52 weeks, 76 weeks, and 104 weeks after infusion

• Proportion of Patients Achieving Histologic Remission

  On the day of cell infusion, and at 28 days, 12 weeks, 24 weeks, 26 weeks, 52 weeks, 76 weeks, and 104 weeks after infusion

• Proportion of Patients Achieving Clinical Response

  On the day of cell infusion, and at 28 days, 12 weeks, 24 weeks, 26 weeks, 52 weeks, 76 weeks, and 104 weeks after infusion

• Proportion of Patients Who Were on Oral Glucocorticoids at Baseline

  On the day of cell infusion, and at 28 days, 12 weeks, 24 weeks, 26 weeks, 52 weeks, 76 weeks, and 104 weeks after infusion

• Changes in C-Reactive Protein (CRP)

  On the day of cell infusion, and at 28 days, 12 weeks, 24 weeks, 26 weeks, 52 weeks, 76 weeks, and 104 weeks after infusion

Study Arms (1)

CART Treatment Group

EXPERIMENTAL

In this group, participants will receive the infusion of RD06-05 cell injection.

Drug: RD06-05 CART Cell Infusion

Interventions

RD06-05 CART Cell Infusion DRUG

Participent will receive the infusion of RD06-05 cell injection with dosage of 3, 6, or 10×10⁶ CAR+T cells/kg respectively

CART Treatment Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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).
• Renal function: Creatinine ≤ 1.5 × ULN or Creatinine Clearance ≥ 40 ml/min.
• Complete blood count: Neutrophil count ≥ 1 × 10⁹/L; Hemoglobin ≥ 60 g/L; Platelet count ≥ 20 × 10⁹/L; Lymphocyte count \> 0.3 × 10⁹/L.
• Coagulation function: International Normalized Ratio (INR) ≤ 1.5 × ULN, or Prothrombin Time (PT) ≤ 1.5 × ULN.
• Oxygen saturation (SpO₂) ≥ 92% in room air at rest.
• 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.
• 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.
• 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.
• 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).
• Confirmed that the extent of ulcerative colitis lesions involves above the rectosigmoid junction (approximately ≥ 15 cm from the anal verge).
• 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).

You may not qualify if:

• 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.
• Administration 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).
• Participation 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.
• Concomitant diseases requiring systemic treatment with therapeutic doses of glucocorticoids (except glucocorticoid treatment for adrenal insufficiency).
• Positive 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.
• Patients with a history of lymphoma, leukemia, or any malignant tumor within the past 10 years are not allowed to enroll.

Sponsors & Collaborators

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

Study Sites (1)

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

Wuhan, Hubei, 430022, China

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Xiaohua Hou, Prof.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruohang He, Attending Physician

CONTACT

027-85726057; 1056610988@qq.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an open-label, single-arm clinical study, in which all enrolled patients will receive the infusion of RD06-05 cell infusion. 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).

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 30, 2025
• Study Start: December 20, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)