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

Sponsor
Antengene Biologics Limited
Study ID
NCT07732309
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ATG-201 — DRUG
    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.

Study Details

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

Key Dates

First listed
Jul 28, 2026
Start date
Sep 1, 2026
Status verified
Jul 2026
Primary completion
Dec 1, 2028
Completion
Jun 1, 2029

Study Design

Enrollment
149 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ATG-201
    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). Part I (Dose Escalation) consists of 2 dosing stages: Single Ascending Dose (SAD) and Step-Up Dose (SUD). A total of 9 dose levels is preset: 0.01 μg/kg, 0.2 μg/kg, 3 μg/kg, 10 μg/kg, 30 μg/kg, 100 μg/kg, 300 μg/kg, 900 μg/kg, and 1500 μg/kg. In Part II (Dose Expansion), the OBD(s) will be further explored and evaluated in 2 selected indications out of SLE, SSc and SjD.

Primary Outcome Measure

Safety and TolerabilitySafety and Tolerability [ Time Frame: 48 weeks ]

Central Contacts

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