A Study to Evaluate the Safety and Efficacy of ATHENA CAR-T in Subjects With Systemic Lupus Erythematosus

Launched by EDIGENE INC. · Apr 16, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called ATHENA CAR-T for adults with moderate to severe Systemic Lupus Erythematosus (SLE), which is a chronic autoimmune disease where the immune system attacks the body's own tissues. The main goal of the study is to see if this treatment is safe and how well it works for patients. To participate, individuals need to be between 18 and 56 years old, have a confirmed diagnosis of SLE, and have been experiencing active symptoms despite at least six months of standard treatment.

Participants will first undergo a preparatory treatment to lower their immune cells, then receive the ATHENA CAR-T injection, and will be monitored for up to 24 months afterward. It’s important to note that this trial is not yet recruiting participants, and those who join will need to agree to use effective birth control if they have a fertile partner for 24 months after receiving the treatment. The trial has specific criteria for who can participate, including some health conditions that would exclude a person from joining, so it's essential to discuss eligibility with a healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or Female, between 18 and 56 years old;
• • diagnosed with SLE according to 2019 EULAR/ACR SLE classifications;
• • anti-Nuclear Antigen Ab positive (titer NLT 1:80) and/or dsDNA ab positive and/or Anti-Sm ab positive at screening;
• • at screening, SLEDAI-2000 scoring NLT 8 points, if low complement scoring and/or anti-dsDNA ab scoring is available, the SLEDAI-2000 scoring except low complement and anti-dsDNA ab should be NLT 6 points;
• • should be subjected to at least 6 months of standard treatment for SLE, and disease active at least two months before screening;
• • good organ functions;
• • trial participants whose partner is fertile agree to use effective contraceptives til 24 months post transfusion, fertile female participants should have negative urine/blood pregnancy test results (participants who were sterilized or menopause for MT 12 months is not considered fertile);
• • voluntary participates this trial and can comprehend and sign ICF.
• Exclusion Criteria:
• • Had or has active malignancy;
• • had been subjected to treatment by CD19 targeted therapy or CAR-T therapy or any gene therapy;
• • within 8 weeks before screening, had CNS disease caused by SLE or non-SLE diseases;
• • within 8 weeks before screening, had lupus crisis;
• • has following kidney diseases: within 8 weeks before randomization, had SLE with serious kidney involvement or need treatment using medications prohibited by protocol to treat active nephritis, or need hemodialysis or need treatment by prednisone MT 100mg/d for longer than 14d or equivalent therapy;
• • had serious allergy to any lymphodepletion medication or ingredients of ATHENA CAR-T;
• • has uncontrolled fungi, bacterial or viral infection or other infections investigator deemed not suitable to participate in the study;
• • combined with other autoimmune disease that needs treatment;
• • pregnant or lactating women;
• • has other factors that deemed not suitable by investigator.