Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection f… (NCT07246096) | Clinical Trial Compass
RecruitingEarly Phase 1
Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
China60 participantsStarted 2026-02-20
Plain-language summary
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA U CAR T cells in patients with autoimmune diseases.
60 patients are planned to be enrolled in the dose-escalation trial.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Age: ≥ 18 years old and ≤ 70 years old, male or female;
✓. The functions of critical organs meet the following requirements:
✓. Subject have previous diagnosis of systemic lupus erythematosus (SLE) (according to the 1997 American College of Rheumatology revised SLE classification criteria, the 2012 Systemic Lupus International Collaborating Clinics classification criteria, or the 2019 European League Against Rheumatism/American College of Rheumatology joint classification criteria);
✓. Subjects had a modified SLEDAI-2K score of ≥8 at screening;
✓. Subject has ≥ 1 organ system with BILAG-2004 Class A mobility score or ≥ 2 organ systems with BILAG-2004 Class B mobility score at screening;
✓. Based on the results of the central laboratory tests at screening, the subject meets one of the following: a. ANA by immunofluorescence ≥ 1:80 b. Anti-dsDNA antibodies above the normal level c. Anti-Smith antibodies above the normal level.
✓. Meets 2013 ACR classification criteria for systemic sclerosis;
✓. If combined with interstitial pneumonia, interstitial changes suggestive of ground-glass exudates on chest HRCT and FVC or DLCO \<70% predictive value on pulmonary function tests;
Exclusion criteria
✕. Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine, tozumabs), or subjects with a history of severe allergic reactions;
What they're measuring
1
Incidence of Dose-Limiting Toxicity (DLT)
Timeframe: up to 52 weeks after infusion
2
Incidence of Treatment Emergent Adverse Events (TEAEs)
. Existence or suspicion of uncontrollable or treatable fungal, bacterial, viral or other infections;
✕. Subjects with central nervous system disorders caused by ADs or not caused by ADs (including epilepsy, psychiatric disorders, organic encephalopathy syndromes, cerebrovascular accidents, encephalitis, central nervous system vasculitis);
✕. Subjects s with relatively serious heart diseases, such as angina pectoris, myocardial infarction, heart failure, and arrhythmia;
✕. Subjects with congenital immunoglobulin deficiency;
✕. Subjects with malignant tumors (except for non-melanoma skin cancer and in situ cervical, bladder, and breast cancers that have been disease free for more than 5 years);
✕. Subjects with end-stage renal failure;
✕. Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis,B core antibody (HBcAb) and HBV DNA titer in peripheral blood higher than the upper limit of detection; Patients with positive hepatitis C virus (HCV) antibodies and positive peripheral blood HCV RNA; People who are positive for human immunodeficiency virus (HIV) antibodies; Those who have tested positive for syphilis;