Rheumatoid Arthritis (RA)Phase 1NCT07100873
A Phase 1 Study of ADI-001 in Rheumatoid Arthritis
A Phase 1 study testing ADI-001, Fludarabine and Cyclophosphamide in people with Rheumatoid Arthritis (RA), run by Adicet Therapeutics at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- ADI-001, Fludarabine and Cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2025to 30 Mar 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Adicet Clinical Trials
Shanghai, Shanghai Municipality
Adicet Clinical Trials, 021-61673760, yding@shanghaiadicet.cn
About this study
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
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)
- Being tested
- ADI-001, Fludarabine, Cyclophosphamide
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADI-001Drug
Anti-CD20 CAR-T
FludarabineDrug
Chemotherapy for Lymphodepletion
CyclophosphamideDrug
Chemotherapy for Lymphodepletion
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Run-in | Experimental | Not described Receives: Drug: ADI-001; Drug: Fludarabine; Drug: Cyclophosphamide |
| Experimental: Part 1a | Experimental | Cy/Flu LD Receives: Drug: ADI-001; Drug: Fludarabine; Drug: Cyclophosphamide |
| Experimental: Part 1b | Experimental | Cy-only LD Receives: Drug: ADI-001; Drug: Cyclophosphamide |
| Experimental: Part 2a | Experimental | Cy/Flu LD Receives: Drug: ADI-001; Drug: Fludarabine; Drug: Cyclophosphamide |
| Experimental: Part 2b | Experimental | Cy-only LD Receives: Drug: ADI-001; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start10 Oct 2025
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adicet Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100873
- Sponsor's protocol ID
- ADI-001-106
- Status last verified
- Dec 2025
- First submitted
- 28 Jul 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07100873
- Acronym / sponsor ID
- ADI-001-106
- Conditions
- Rheumatoid Arthritis (RA)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Adicet TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Experimental: Run-in | Experimental | Drug: ADI-001, Drug: Fludarabine, Drug: Cyclophosphamide |
| Experimental: Part 1a | Experimental | Drug: ADI-001, Drug: Fludarabine, Drug: CyclophosphamideCy/Flu LD |
| Experimental: Part 1b | Experimental | Drug: ADI-001, Drug: CyclophosphamideCy-only LD |
| Experimental: Part 2a | Experimental | Drug: ADI-001, Drug: Fludarabine, Drug: CyclophosphamideCy/Flu LD |
| Experimental: Part 2b | Experimental | Drug: ADI-001, Drug: CyclophosphamideCy-only LD |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADI-001Anti-CD20 CAR-T | Drug | Experimental: Part 1a, Experimental: Part 1b, Experimental: Part 2a, Experimental: Part 2b, Experimental: Run-in |
| FludarabineChemotherapy for Lymphodepletion | Drug | Experimental: Part 1a, Experimental: Part 2a, Experimental: Run-in |
| CyclophosphamideChemotherapy for Lymphodepletion | Drug | Experimental: Part 1a, Experimental: Part 1b, Experimental: Part 2a, Experimental: Part 2b, Experimental: Run-in |
Primary outcome
The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort
Time frame: 28 days
This primary endpoint will be used to evaluate safety and tolerability of AD1-001 in subjects with treatment-refractory RA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADI-001, Fludarabine and Cyclophosphamide in people with Rheumatoid Arthritis (RA), run by Adicet Therapeutics at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adicet Medical Monitor (021-61673760, lma@shanghaiadicet.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.