A Study of ATG-201 in Adult Participants With Autoimmune Diseases

Официальное название

A Phase I, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of ATG-201 in Adult Participants With Autoimmune Diseases

Обзор

This is a phase I, open-label study of ATG-201 in participants with autoimmune diseases.

Подробное описание

This is a phase I, open-label, first-in-human clinical trial to evaluate the safety, tolerability, PK, PD, immunogenicity, and preliminary efficacy of ATG-201 in participants with autoimmune diseases. The study will be conducted in 2 parts: Dose Escalation (Part I) and Dose Expansion (Part II).

Вмешательства

• Препарат ATG-201
  ATG-201 is a recombinant, human IgG1-like TCE that simultaneously binds to human CD3 and CD19. The primary packaging used for ATG-201 injection consists of 2 mL middle-boro injection vial (2 mL-Pro), sealed with 13 mm stopper gray with B2 coating and 13 FO LQ 3769 blue cap. The production specification is 20 mg/vial.

Первичные конечные точки

• Safety and TolerabilitySafety and Tolerability [Срок оценки: 48 weeks]

Критерии участия

Критерии включения

• Participants who give consent to this study participation and sign informed consent form.
• Participants at least 18 years of age inclusive at screening visit.
• Must be able to adhere to the study visit schedule and other protocol .requirements.
• Female of childbearing potential must agree to use adequate contraceptive measures from 28 days before starting study treatment to until 48 weeks after last dose of treatment, not breastfeeding, and have a negative serum pregnancy test at screening.
• Male participants must agree to use an effective barrier method of contraception during sexual contact with a female of childbearing potential during screening and throughout the study until 48 weeks after the final dose of study treatment.

SLE: subjects:

• Have a confirmed diagnosis of SLE and meet the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria at screening.
• Have active SLE disease.
• Have had previous treatment failure.

Критерии исключения

• Intolerance or allergy to the investigational product, or to any component thereof, or to any concomitant medications that may be used in the study (e.g., tocilizumab).
• Presence of central nervous system disorders of either autoimmune or non-autoimmune etiology, including but not limited to: epilepsy, psychotic disorders, organic brain syndrome, cerebrovascular accident, encephalitis, or central nervous system vasculitis.
• Catastrophic or severe antiphospholipid syndrome within 12 months prior to screening or during screening.
• Severe (requiring oxygen support) or rapidly progressing interstitial lung disease.
• Uncontrolled other diseases: history or clinical evidence of active significant acute or chronic diseases (i.e., cardiovascular, pulmonary, untreated hypertension, anemia, gastrointestinal, hepatic, renal, neurological, cancer, or infectious diseases) which, in the opinion of the investigator, could confound the results of the study or put the participant at undue risk.
• History of a major organ transplant (e.g. heart, lung, renal, liver) or hematopoietic stem cell/marrow transplant.
• Have a planned surgical procedure, or a history of any other medical disease, or laboratory abnormalities, or conditions which would make the participant (in the opinion of the investigator) unsuitable for the study.
• Received intravenous immunoglobulin, plasmapheresis, hemodialysis, intravenous cyclophosphamide, or high dose prednisone and its equivalents (>60 mg/day) within 2 months prior to screening.
• Live or attenuated vaccine within 28 days prior to screening or during screening.
• Participants who have evidence of serious suicide risk including any history of suicidal behavior in the last 6 months or who, in the investigator's opinion, pose a significant suicide risk.
• The participant has an abnormality on 12-lead electrocardiogram at screening which is clinically significant in the opinion of the investigator, and which could confound the results of the study.

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 · 22 центра

• The First Affiliated Hospital of Bengbu Medical University — Bengbu
• The First Affiliated Hospital of University of Science and Technology of China — Хэфэй
• Peking University People's Hospital — Пекин
• The First Affiliated Hospital of Xiamen University — Xiamen
• Nanfang Hospital of Southern Medical Universit — Гуанчжоу
• Sun Yat-sen Memorial Hospital, Sun Yat-sen Universit — Гуанчжоу
• The First Affiliated Hospital of Guangzhou University of Chinese Medicine — Гуанчжоу
• The First Affiliated Hospital of Sun Yat-sen University — Гуанчжоу
• … и ещё 14 центров

Идентификаторы

NCT: NCT07732309 · ATG-201-AID-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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