A Phase 1 Study of ADI-001 in Rheumatoid Arthritis

NCT ID: NCT07100873

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-10

Study Completion Date

2028-03-30

Brief Summary

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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

Detailed Description

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Conditions

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Rheumatoid Arthritis (RA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental: Run-in

Group Type EXPERIMENTAL

ADI-001

Intervention Type DRUG

Anti-CD20 CAR-T

Fludarabine

Intervention Type DRUG

Chemotherapy for Lymphodepletion

Cyclophosphamide

Intervention Type DRUG

Chemotherapy for Lymphodepletion

Experimental: Part 1a

Cy/Flu LD

Group Type EXPERIMENTAL

ADI-001

Intervention Type DRUG

Anti-CD20 CAR-T

Fludarabine

Intervention Type DRUG

Chemotherapy for Lymphodepletion

Cyclophosphamide

Intervention Type DRUG

Chemotherapy for Lymphodepletion

Experimental: Part 1b

Cy-only LD

Group Type EXPERIMENTAL

ADI-001

Intervention Type DRUG

Anti-CD20 CAR-T

Cyclophosphamide

Intervention Type DRUG

Chemotherapy for Lymphodepletion

Experimental: Part 2a

Cy/Flu LD

Group Type EXPERIMENTAL

ADI-001

Intervention Type DRUG

Anti-CD20 CAR-T

Fludarabine

Intervention Type DRUG

Chemotherapy for Lymphodepletion

Cyclophosphamide

Intervention Type DRUG

Chemotherapy for Lymphodepletion

Experimental: Part 2b

Cy-only LD

Group Type EXPERIMENTAL

ADI-001

Intervention Type DRUG

Anti-CD20 CAR-T

Cyclophosphamide

Intervention Type DRUG

Chemotherapy for Lymphodepletion

Interventions

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ADI-001

Anti-CD20 CAR-T

Intervention Type DRUG

Fludarabine

Chemotherapy for Lymphodepletion

Intervention Type DRUG

Cyclophosphamide

Chemotherapy for Lymphodepletion

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Adicet Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Adicet Clinical Trials

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Adicet Medical Monitor

Role: CONTACT

021-61673760

Facility Contacts

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Adicet Clinical Trials

Role: primary

021-61673760

Other Identifiers

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ADI-001-106

Identifier Type: -

Identifier Source: org_study_id

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