Phase 1 Study of ADI-001 Anti-CD20 CAR-T Cells for Adults with Treatment-Resistant Rheumatoid Arthritis

What this Trial Is About

Researchers are conducting a phase 1 clinical trial to study ADI-001, an Anti-CD20 CAR-engineered allogeneic gamma-delta T cell therapy, in adults with treatment-refractory Rheumatoid Arthritis RA. The trial aims to compare two different lymphodepletion regimens to assess safety and dose-limiting toxicities in participants whose RA has not responded to standard treatments. This study uses a randomized, single-blind, parallel group design to evaluate these approaches. The study involves several treatment periods including screening, lymphodepletion LD, treatment with ADI-001, and follow-up. Participants are assigned to one of two lymphodepletion regimens a combination of cyclophosphamide and fludarabine CyFlu LD or cyclophosphamide alone Cy-only LD. The trial consists of experimental phases labeled as Run-in, Part 1a, Part 1b, Part 2a, and Part 2b, each assessing different aspects of the treatment process. Participants will undergo assessments throughout the study to monitor safety, including laboratory tests and evaluations of vital organ function. Researchers will specifically measure the incidence of dose-limiting toxicities within 28 days after dosing. The trial includes extended safety monitoring to ensure participant well-being during and after treatment. The overall duration and detailed follow-up procedures are structured to comprehensively evaluate treatment effects and safety.

A Phase 1 Study of ADI-001 in Rheumatoid Arthritis