Inaticabtagene Autoleucel Injection in the Treatment of Refractory Systemic Lupus Erythematosus-r… (NCT06826430) | Clinical Trial Compass
RecruitingPhase 1
Inaticabtagene Autoleucel Injection in the Treatment of Refractory Systemic Lupus Erythematosus-related Immune Thrombocytopenia
China12 participantsStarted 2025-03-01
Plain-language summary
This is a single-arm, open-label，phase I clinical study to evaluate the safety and tolerability of Inaticabtagene Autoleucel Injection in treatment of refractory systemic lupus erythematosus-related immune thrombocytopenia.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Age range: 18-70 years (including 18 and 70 years), regardless of gender.
✓. Clinically diagnosed with Refractory Systemic Lupus Erythematosus-related Immune Thrombocytopenia according to the revised criteria of ACR in 1997 or EULAR/ACR in 2019. At least two consecutive blood routine tests showing platelet counts \<50×10\^9/L; Peripheral blood smear microscopy showed no significant abnormalities in the morphology of blood cells; The morphological characteristics of bone marrow cells are consistent with immune thrombocytopenia. Treated at least 1 course of MP shock therapy or high-dose steroids, combined with one or more immunosuppressive agents (including biologics) for at least 3 months but not achieving partial remission, or the efficacy cannot be maintained during the steroid reduction process.
✓. During the study period, the use of corticosteroids at a dose not exceeding 10mg prednisone or its equivalent, all immunosuppressants (excluding hydroxychloroquine) should be discontinued.
✓. Women of childbearing potential must have a negative blood pregnancy test 7 days prior to trial conditioning therapy; any male and female patients of childbearing potential must agree to use an effective method of contraception throughout the study and for at least 2 year following infusion of CAR-T cells. Childbearing potential is biologically capable of bearing a living baby and sexually active. Female patients who were not of childbearing potential (ie, met at least 1 of the following criteria):
✓. Adequate organ function according to the following criteria:
Exclusion criteria
✕. Severe active central nervous system (CNS) lupus, including seizures, psychosis, cerebrovascular accidents, or CNS vasculitis requiring therapeutic intervention within 60 days after baseline.
What they're measuring
1
Incidence of Treatment-related Adverse Events
Timeframe: Up to 28 days post-infusion
2
The safe dosage for a single infusion of Inaticabtagene Autoleucel Injection
. Dialysis patients or creatinine clearance rate less than 30mL/min.
✕. Pregnancy or breastfeeding.
✕. Merge active infections (such as sepsis, bacteremia, mycosis, uncontrolled lung infections, and active tuberculosis).
✕. Hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg) are positive; Hepatitis B e antibody (HBe Ab) and/or hepatitis B core antibody (HBcAb) are positive, and the number of HBV-DNA copies is greater than the measurable lower limit; Hepatitis C (HCV) antibody positive; positive for human immunodeficiency virus (HIV) antibodies; positive for syphilis antibody (TP Ab);
✕. Major surgery that was assessed as unsuitable by the investigators within 4 weeks before screening.
✕. Patients with concurrent active malignancy within the past five years, those with a history of malignancy but cuired are eligible.
✕. The patient's heart meets any of the following conditions: