A Phase 1 interventional study of ADI-001 and Fludarabine in Rheumatoid Arthritis (RA), sponsored by Adicet Therapeutics. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-08.
Sponsored by Adicet Therapeutics · Phase 1, Interventional, and Treatment
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
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's planned enrollment of 25 is below the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Adicet Therapeutics is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: ADI-001 · Drug: Fludarabine · Drug: Cyclophosphamide
Cy/Flu LD
Drug: ADI-001 · Drug: Fludarabine · Drug: Cyclophosphamide
Cy-only LD
Drug: ADI-001 · Drug: Cyclophosphamide
Cy/Flu LD
Drug: ADI-001 · Drug: Fludarabine · Drug: Cyclophosphamide
Cy-only LD
Drug: ADI-001 · Drug: Cyclophosphamide
Anti-CD20 CAR-T
Chemotherapy for Lymphodepletion
Chemotherapy for Lymphodepletion
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
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Mar 2027, 17 months after the start.
Of 128 industry-sponsored phase 1 interventional studies under Arthritis, Rheumatoid, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 32. This study's planned 17 months is above that.
Counting every sponsor, half of 148 studies reached it within 16 months; a quarter within 5 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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