A Phase 1 Study of ADI-001 in Rheumatoid Arthritis

Adicet Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Rheumatoid Arthritis (RA)

Treatments: Drug: ADI-001; Drug: Cyclophosphamide; Drug: Fludarabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT07100873

ADI-001-106

Details and patient eligibility

About

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

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ≥ 18 years of age.
2. Fulfills the 2010 ACR-EULAR RA classification criteria
3. Agreement not to take traditional medicines and medications not prescribed by a doctor
4. Adequate hematological, liver, cardiac and pulmonary function

Exclusion criteria

1. Presence of severe liver disease, Child-Pugh class B or C.
2. Autoimmune disease requiring prednisone higher than 0.5 mg/kg/day (or corticosteroid equivalent).
3. Subjects unwilling to participate in an extended safety monitoring period (LTFU protocol)
4. 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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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25 participants in 5 patient groups

Experimental: Run-in

Experimental group

Treatment:

Drug: Fludarabine

Drug: Cyclophosphamide

Drug: ADI-001

Experimental: Part 1a

Experimental group

Description:

Cy/Flu LD

Treatment:

Drug: Fludarabine

Drug: Cyclophosphamide

Drug: ADI-001

Experimental: Part 1b

Experimental group

Description:

Cy-only LD

Treatment:

Drug: Cyclophosphamide

Drug: ADI-001

Experimental: Part 2a

Experimental group

Description:

Cy/Flu LD

Treatment:

Drug: Fludarabine

Drug: Cyclophosphamide

Drug: ADI-001

Experimental: Part 2b

Experimental group

Description:

Cy-only LD

Treatment:

Drug: Cyclophosphamide

Drug: ADI-001