FIT-(BCMA+CD19)-CAR-T Cells in Recurrent/Refractory Autoimmune Diseases Patients.

NCT07604792 | Enrolling By Invitation Early Phase 1

• 1 other identifier: BCMA/CD19-CN-A1
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-center, open-label, single-dose exploration clinical trial for treating patients with partially relapsed/refractory autoimmune diseases by infusing FIT-(BCMA+CD19)-CAR-T cells after pre-treatment with cleansing therapy. In this study phase, a traditional "3+3" trial design is employed for dose escalation.

Conditions

Autoimmune Diseases

Outcome Measures

Primary Outcomes (2)

• Incidence of dose-limiting toxicity

  The proportion of patients receiving CAR-T cells who encounter dose-limiting toxicities (DLTs). Safety evaluations are performed in accordance with the NCI-CTCAE version 5.0 standards (Cytokine Release Syndrome and neurotoxicity will be graded based on ASTCT/ASBMT grading criteria).

  Up to 28 days from CAR-T infusion

• Incidence Incidence Incidence of dose-limiting toxicity

  The proportion of patients receiving CAR-T cells who encounter dose-limiting toxicities (DLTs). Safety evaluations are performed in accordance with the NCI-CTCAE version 5.0 standards (Cytokine Release Syndrome and neurotoxicity will be graded based on ASTCT/ASBMT grading criteria).

  Up to 28 days from CAR-T infusion

Study Arms (1)

FIT-(BCMA+CD19)-CAR-T Cells

EXPERIMENTAL

FIT-(BCMA+CD19)-CAR-T cells infusion. Infusion doses: The planned infusion doses are as follows: the first dose group at 1×10\^5 cells/kg; the second dose group at 3×10\^5 cells/kg; the third dose group at 1×10\^6 cells/ kg. Infusion doses refer to the number of CAR-positive cells.

Biological: FIT-(BCMA+CD19)-CAR-T Cells

Interventions

FIT-(BCMA+CD19)-CAR-T Cells BIOLOGICAL

Before cell infusion, researchers may decide, based on necessity, whether to administer prophylactic medication, which may include options such as acetaminophen and diphenhydramine, or H1 antihistamines, among others. Subjects are allowed to receive adequate supportive care after FIT-(BCMA+CD19)-CAR-T cells infusion, including blood transfusions and blood products, antibiotic therapy, antiemetics, antidiarrheals, analgesics, etc.

FIT-(BCMA+CD19)-CAR-T Cells

Eligibility Criteria

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

You may qualify if:

• Voluntary participation in the clinical study, with the subject or their legally authorized representative fully understanding and providing written informed consent (ICF) for this study, and willingness to comply with and complete all trial procedures.
• Aged 18 to 70 years.
• ECOG performance status ≤ 2.
• Life expectancy of at least 12 weeks.
• Adequate venous access for apheresis and no other contraindications to blood cell separation.
• Laboratory parameters at screening must meet the following requirements, with no receipt of cell growth factors within 7 days (or 2 weeks for long-acting formulations) prior to the screening hematology assessment:
• Absolute neutrophil count ≥ 1.0 × 10⁹/L. Hemoglobin ≥ 60 g/L (without red blood cell transfusion within 14 days). Platelet count ≥ 50 × 10⁹/L (thrombocytopenia due to autoimmune disease may be excluded at the investigator's discretion).
• Absolute lymphocyte count (ALC) ≥ 0.5 × 10⁹/L. Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN). Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (acute elevations due to autoimmune disease may be excluded at the investigator's discretion).
• Creatinine clearance (Cockcroft-Gault formula) ≥ 30 mL/min.
• Cardiac ejection fraction ≥ 45%, no pericardial effusion (excluding minimal or physiological effusion) confirmed by echocardiography (ECHO), and no clinically significant findings on electrocardiogram (ECG).
• Baseline oxygen saturation \> 92% while breathing room air.
• Female subjects of childbearing potential must have a negative serum or urine pregnancy test (women who have undergone surgical sterilization or have been postmenopausal for at least 2 years are not considered to be of childbearing potential).
• Male and female subjects willing to practice contraception from the time of signing the ICF until 12 months after the last dose of study drug.

You may not qualify if:

• Active central nervous system (CNS) disease, such as epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
• Presence or suspicion of fungal, bacterial (including but not limited to Mycobacterium tuberculosis), viral, or other infection that is uncontrolled or requires intravenous antifungal, antibacterial, or antiviral therapy; uncomplicated urinary tract infection and uncomplicated bacterial pharyngitis are permitted.
• Hepatitis B (positive for hepatitis B surface antigen \[HBsAg\] with HBV DNA \> 1000 copies/mL), hepatitis C (positive for hepatitis C antibody), syphilis infection (positive for antibody), or human immunodeficiency virus (HIV) infection.
• Prior or concomitant medication:
• Prior use of any CAR-T cell product or other genetically modified T-cell therapy.
• History of CD19-targeted therapy. Receipt of live vaccine within 4 weeks before enrollment. Use of another investigational medicinal product within 30 days before screening.
• Receipt of biologic macromolecular drugs (e.g., rituximab, belimumab, telitacicept, adalimumab, etanercept, etc.) that have therapeutic effects on the target indication within 4 weeks or 5 half-lives before enrollment.
• Receipt of \> 20 mg/day of prednisone or equivalent doses of other corticosteroids within 2 weeks before enrollment.
• Receipt of conventional synthetic disease-modifying drugs (e.g., cyclophosphamide, methotrexate, leflunomide, sulfasalazine, etc.) that have therapeutic effects on the target indication within 2 weeks before enrollment.
• History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months before enrollment.
• History of genetic syndromes associated with bone marrow failure, such as Fanconi anemia, Kostmann syndrome, Schwachman-Diamond syndrome, etc.
• History of lymphoproliferative disease or malignancy (except for basal cell carcinoma of the skin, in situ carcinoma of the breast/cervix, and other diseases that are disease-free and have not been treated within the past five years).
• Women of childbearing potential who are pregnant or breastfeeding.
• Any medical activity that may interfere with the evaluation of study safety or efficacy.
• In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up, or to comply with the requirements for study participation.

Sponsors & Collaborators

• Beijing Boren Hospital: lead

Study Sites (1)

Beijing Gaobo Boren Hospital Co., Ltd

Beijing, China

Location

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

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

Study Record Dates

• First Submitted: May 17, 2026
• First Posted: May 22, 2026
• Study Start: September 25, 2025
• Primary Completion: November 7, 2025
• Study Completion (Estimated): November 30, 2041
• Last Updated: May 22, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)