CYTB323L12201: Phase II study of YTB323 in DM, ASyS or IMNM
Research type
Research Study
Full title
A Phase 2, randomized, open-label, controlled study to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe refractory idiopathic inflammatory myopathies
IRAS ID
1009384
Contact name
Léa Dusuel
Contact email
Clinicaltrials.gov Identifier
Research summary
The purpose of this trial is to compare the effects of YTB323 with comparator treatment in people with difficult to treat severe idiopathic inflammatory myopathies, also known as myositis. Myositis is a group of rare diseases in which a person’s immune system attacks their own muscles. This may cause symptoms like muscle weakness, pain, and skin rash.YTB323 is a type of treatment called chimeric antigen receptor (CAR) T cell therapy. In CAR T cell therapy, a person’s T cells are collected, modified in the lab to identify and destroy immune B cells that believed to contribute to myositis. Modified T-cells are then put back into the person’s body. Before giving YTB323 CAR T-cell therapy, people often receive treatment called XX to improve the chances of this YTB323 CAR T-cell therapy working. The conditioning treatment used in this study includes XX to help get the body ready so that YTB323 can work best. Comparator treatment includes approved treatment(s) for severe myositis. These treatments are XX. The trial doctor will select which treatment the participants will receive in this trial. The study has 2 parts. At least X participants are expected to join Part 1 and about X participants are expected to join Part 2.In Part 1, all participants will receive YTB323 infusion. In Part 2 participants will be randomly placed into 1 of 2 groups. In Group 1, participants will receive YTB323 and in Group 2, participants will receive a comparator treatment decided by the study doctor. Participants receiving YTB323 will be hospitalised to receive the infusion and monitored for side effects during hospitalization and frequent visits until 8 weeks after YTB323 administration. Then, monthly until Week 24 followed by about 12-14 weeks until Week 76, then approximately every 6 months till the end of study at Week X.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
24/SC/0340
Date of REC Opinion
6 Dec 2024
REC opinion
Further Information Favourable Opinion