Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ADI-001 · 2 trials · 8 indications
This primary endpoint will be used to evaluate safety and tolerability of AD1-001 in subjects with treatment-refractory RA
This primary endpoint will be used to determine the MTD/MAD of ADI-001
| Arm | Type | Description |
|---|---|---|
| Experimental: Run-in | EXPERIMENTAL | - |
| Experimental: Part 1a | EXPERIMENTAL | Cy/Flu LD |
| Experimental: Part 1b | EXPERIMENTAL | Cy-only LD |
| Experimental: Part 2a | EXPERIMENTAL | Cy/Flu LD |
| Experimental: Part 2b | EXPERIMENTAL | Cy-only LD |
| ADI-001 Dose Escalation | EXPERIMENTAL | ADI-001 is administered via infusion with ascending dose levels as a single dose to determine the maximum tolerated dose (MTD) or maximum assessed dose (MAD) of ADI-001. |
| ADI-001 Dose Extension | EXPERIMENTAL | After dose level has been declared safe, additional patients can be enrolled at the declared safe dose to further investigate the safety profile of ADI-001. Dose extension patients will not contribute to the determination of MTD/MAD and DLT evaluation. |
| ADI-001 Dose Expansion | EXPERIMENTAL | Dose Expansion ADI-001 is administered via infusion at the MTD/MAD to confirm recommended phase 2 dose (Part 2). |
| Name | Type | Description |
|---|---|---|
| ADI-001 | DRUG | Anti-CD20 CAR-T |
| Fludarabine | DRUG | Chemotherapy for Lymphodepletion |
| Cyclophosphamide | DRUG | Chemotherapy for Lymphodepletion |
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 ...
ADI-001 is an investigational therapy being studied for autoimmune diseases, including Lupus Nephritis and Rheumatoid Arthritis (RA). It is also being evaluated in a clinical trial for conditions such as Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), ANCA-Associated Vasculitis (AAV), Idiopathic Inflammatory Myopathies, and Stiff Person Syndrome. It is not yet approved by the FDA.
ADI-001 is being developed by Adicet Bio, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ACET. The company is conducting clinical trials to evaluate the drug's safety and efficacy in autoimmune diseases.
ADI-001 is in Phase 1 clinical development. It is an investigational drug, meaning it has not received FDA approval and is still being studied in clinical trials. The drug has been granted Fast Track designation by the FDA, which may expedite its development and review.
ADI-001 is being studied in two Phase 1 clinical trials. The first, NCT06375993, is enrolling by invitation in the United States and includes patients with Lupus Nephritis, autoimmune diseases, and other conditions. The second, NCT07100873, is recruiting in China for Rheumatoid Arthritis. Both trials are controlled but not randomized or double-blind.
Yes, ADI-001 is also known as Prulacabtagene Leucel (Prula-cel). The drug was formerly called ADI-001 and is now referred to by this alternative name in clinical trial documentation. Both names refer to the same investigational therapy being developed by Adicet Bio.