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 ...