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Recruiting NCT07100873

A Phase 1 Study of ADI-001 in Rheumatoid Arthritis

Phase I Interventional Rheumatoid Arthritis (RA)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ADI-001, Fludarabine, Cyclophosphamide.
Who it may be relevant to
Registry conditions: Rheumatoid Arthritis (RA). Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

Interventions

  • Drug ADI-001
    Anti-CD20 CAR-T
  • Drug Fludarabine
    Chemotherapy for Lymphodepletion
  • Drug Cyclophosphamide
    Chemotherapy for Lymphodepletion

Primary outcome measures

  • The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort [Time frame: 28 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Adicet Clinical Trials — Shanghai

Identifiers

NCT: NCT07100873 · ADI-001-106

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗