A Phase 1 Study of ADI-001 in Rheumatoid Arthritis

ConditionRheumatoid Arthritis (RA)

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-80

SponsorAdicet Therapeutics

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

25 Participants

are divided into 5 treatment groups

Group A: Experimental: Run-inExperimental treatment 3 interventions

Group B: Experimental: Part 1aExperimental treatment 3 interventions

Group C: Experimental: Part 1bExperimental treatment 2 interventions

Group D: Experimental: Part 2aExperimental treatment 3 interventions

Group E: Experimental: Part 2bExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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

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

Time frame

28 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Adicet Therapeutics

Lead sponsor

Source ClinicalTrials.gov

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