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

Официальное название

A Phase 1 Study to Evaluate the Safety and Efficacy of ATHENA CAR-T in Subjects With Moderate or Severe Systemic Lupus Erythematosus

Обзор

The goal of this clinical trial is to test ATHENA CAR-T injection in adults with moderate to severe Systemic Lupus Erythematosus. The main question it aims to answer is: • To evaluate the safety and tolerability of ATHENA CAR-T. After screening, participants will be subjected to lymphodepletion regimen. After recovery, participants will be injected with ATHENA CAR-T injection and followed up to 24 months.

Подробное описание

This study is a single center, one-arm, open label, phase I study aimed at evaluate the safety and effectiveness of ATHENA CAR-T treating moderate to severe SLE patients.

A traditional "3+3" design is used with two doses. DLT is monitored. Safety and effectiveness are followed up until 24 months post infusion of ATHENA CAR-T. Besides safety monitoring, efficacy is evaluated via SLEDAI-2000, BILAG-2004, PGA.

Вмешательства

• Биопрепарат ATHENA CAR-T
  Phase 1 dose escalation (3+3): dose 1 and dose 2.
• Препарат Fludarabine
  Intravenous injection of fludarabine.
• Препарат Cyclophosphamide
  Intravenous injection of cyclophosphamide.

Первичные конечные точки

• Dose Limiting Toxicity [Срок оценки: 0~28 day after treatment]
• Frequency of AEs, SAEs, lab abnormalities, AESIs [Срок оценки: 0 day to 24 months after treatment]

Вторичные конечные точки (7)

• Efficacy: Percent of patients achieved SRI-4 [Срок оценки: 0 to 16 weeks after treatment]
• Efficacy: Patients SLEDAI-2000 change compared with baseline [Срок оценки: 0 to 16 weeks after treatment]
• Efficacy: Patients BILAG-2004 change compared with baseline [Срок оценки: 0 to 16 weeks after treatment]
• Efficacy: Percent of patients' PGA not worsen [Срок оценки: 0 to 16 weeks after treatment]
• Percent of patients responded by BILAG-2004 [Срок оценки: 0 to 16 weeks after treatment]
• Efficacy: Immunologic parameters [Срок оценки: 0 day to 24 months after treatment]
• Efficacy: Immunologic parameters (cont) [Срок оценки: 0 day to 24 months after treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Henan University of Science and Technology — Luoyang

Идентификаторы

NCT: NCT06373991 · EDI-901-SLE01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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