A Phase 1 Study of ADI-001 in Rheumatoid Arthritis

NCT07100873 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-12-08

No results posted yet for this study

Summary

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

Conditions

  • Rheumatoid Arthritis (RA)

Interventions

DRUG

ADI-001

Anti-CD20 CAR-T

DRUG

Fludarabine

Chemotherapy for Lymphodepletion

DRUG

Cyclophosphamide

Chemotherapy for Lymphodepletion

Sponsors & Collaborators

  • Adicet Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-10
Primary Completion
2027-03-30
Completion
2028-03-30
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07100873 on ClinicalTrials.gov