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NCT Number: NCT07100873

A Phase 1 Study of ADI-001 in Rheumatoid Arthritis

ADI-001-106 is a phase 1 study of ADI-001 with a randomized, single-blind, parallel group design to compare two different LD regimens in subjects with treatment-refractory RA. The study will consist of different periods including screening, LD, treatment, and follow-up

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Key information

Conditions

Rheumatoid Arthritis (RA) Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Adicet Clinical Trials

Shanghai, Shanghai Municipality, China

Location status: Recruiting

Location contact

Adicet Clinical Trials

CONTACT

[email protected]

021-61673760

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 18 years of age.
  • Fulfills the 2010 ACR-EULAR RA classification criteria
  • Agreement not to take traditional medicines and medications not prescribed by a doctor
  • Adequate hematological, liver, cardiac and pulmonary function

Exclusion criteria

  • Presence of severe liver disease, Child-Pugh class B or C.
  • Autoimmune disease requiring prednisone higher than 0.5 mg/kg/day (or corticosteroid equivalent).
  • Subjects unwilling to participate in an extended safety monitoring period (LTFU protocol)
  • History of a clinically significant infection (including sepsis, pneumonia, bacteremia, fungal, viral and opportunistic infections) within 4 weeks prior to first dose of study drug which in the opinion of the Investigator may compromise the safety of the subject in the study.

Treatment and study plan

ADI-001

Drug

Anti-CD20 CAR-T

Fludarabine

Drug

Chemotherapy for Lymphodepletion

Cyclophosphamide

Drug

Chemotherapy for Lymphodepletion

Primary outcomes

  1. The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort

    Time frame: 28 days

    This primary endpoint will be used to evaluate safety and tolerability of AD1-001 in subjects with treatment-refractory RA

Study contacts

Contact information is provided by the study sponsor or research team.

Adicet Medical Monitor

CONTACT

[email protected]

021-61673760

Sponsors and collaborators

Lead sponsor

Adicet Therapeutics

Industry

Registry information

Official study title

A Phase 1 Study of ADI-001 Anti-CD20 CAR-engineered Allogeneic Gamma-Delta (γδ) T Cells in Adults With Treatment-refractory Rheumatoid Arthritis

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 3, 2025
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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