Evaluation of Safety, Pharmacokinetics and Pharmacodynamics of Arnovie101, an mRNA-LNP-Based In Vivo CAR-T Therapy, for the Treatment of B Cell-Mediated Autoimmune Diseases (SLE and AIHA)

Sponsor
Circunited BioPharma (Shenzhen) Co., Ltd.
Study ID
NCT07629596
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Arnovie101 Infusion Intravenous — DRUG
    Dosing will begin at a lower dose level and may be escalated to dose levels considered safe and potentially effective according to the study protocol.

Study Details

This is an open lable and single arm study designed to evaluate the safety, PK and PD of Arnovie101 in B cell-mediated Autoimmune Disease

Key Dates

First listed
Jun 5, 2026
Start date
Apr 7, 2026
Status verified
Jun 2026
Primary completion
May 30, 2027
Completion
May 30, 2027

Study Design

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

Arms

  • Experimental: Arnovie101 treatment group
    Participants will receive Arnovie101 infusion (a nanobody-modified LNP encapsulating mRNA for in vivo CAR-T therapy) at the specified dose level and on the specified study days.

Primary Outcome Measure

Incidence of dose-limiting toxicity (DLT) [ Time Frame: Up to 12 months ]

Central Contacts

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