Actively Recruiting
Inaticabtagene Autoleucel Injection in the Treatment of Refractory Systemic Lupus Erythematosus-related Immune Thrombocytopenia
Led by Juventas Cell Therapy Ltd. · Updated on 2025-08-07
12
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Inaticabtagene Autoleucel Injection in the Treatment of Refractory Systemic Lupus Erythematosus-related Immune Thrombocytopenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years, any gender
- Diagnosed with refractory systemic lupus erythematosus-related immune thrombocytopenia meeting ACR or EULAR/ACR criteria
- At least two consecutive blood tests showing platelet counts below 50 x 10^9/L
- Blood and bone marrow cell morphology consistent with immune thrombocytopenia
- Treated with at least one course of methylprednisolone shock therapy or high-dose steroids plus immunosuppressants for at least 3 months without partial remission or maintained efficacy
- Use of corticosteroids at prednisone 10mg or less, with all immunosuppressants except hydroxychloroquine stopped during study
- Women of childbearing potential must have negative pregnancy test within 7 days before conditioning therapy and agree to use contraception during study and for 2 years after
- Women not of childbearing potential must meet criteria such as hysterectomy, oophorectomy, or medically confirmed menopause
- Adequate organ function including liver enzymes (AST and ALT ≤ 3x ULN), bilirubin ≤ 2x ULN (with exceptions for Gilbert's syndrome), creatinine ≤ 1.5x ULN or creatinine clearance ≥ 60 mL/min
- Minimal pulmonary reserve and oxygen saturation above 91% without oxygen
- Lymphocyte count above 0.4 x 10^9/L
You will not qualify if you...
- Severe active central nervous system lupus requiring intervention within 60 days prior to baseline
- Dialysis or creatinine clearance less than 30 mL/min
- Pregnancy or breastfeeding
- Active infections such as sepsis, bacteremia, fungal infections, uncontrolled lung infections, or active tuberculosis
- Positive for hepatitis B surface or e antigens, hepatitis C antibody, HIV antibodies, or syphilis antibody
- Major surgery deemed unsuitable by investigators within 4 weeks before screening
- Active malignancy within past 5 years (except cured malignancy)
- Heart conditions including LVEF ≤ 45%, NYHA class III or IV heart failure, severe arrhythmias needing treatment (excluding atrial fibrillation and paroxysmal supraventricular tachycardia), prolonged QTcB interval, recent myocardial infarction or heart surgery within 6 months
- Clinically significant pleural effusion
- Vaccination with live vaccine within 6 weeks prior to screening
- Deep vein thrombosis within 6 months or history of pulmonary embolism
- Life expectancy less than 6 months
- Participation in other interventional clinical studies or investigational drug treatments within 3 months or 5 half-lives prior to infusion
- History of epilepsy, cerebral ischemia/hemorrhage, cerebellar disease, or active central nervous system disorders
- Hypersensitivity to components of Inaticabtagene Autoleucel Injection
- Previous CAR-T cell therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
J
Junyin Yu
CONTACT
W
wenqiu Huang, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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