CYTB323J12201: A phase II study of YTB323 in SLE +/- LN
Research type
Research Study
Full title
A Phase 2, adaptive, randomized, open-label, assessor-blinded active-controlled study to evaluate the efficacy and safety of rapcabtagene autoleucel versus Standard of Care in patients suffering from systemic lupus erythematosus (SLE) with active, refractory lupus nephritis (LN)
IRAS ID
1009376
Contact name
Celine Steinmetz
Contact email
Sponsor organisation
Novartis Pharma AG
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to learn about the effects of YTB323 compared with routine treatment in people with difficult to treat active kidney disease caused by systemic lupus erythematosus (SLE).
SLE is the most common type of lupus. Lupus is an autoimmune disease in which a person’s immune system attacks its own tissues and organs. A common complication of SLE is kidney damage due to inflammation (lupus nephritis, LN).
YTB323 is being tested for its effects on SLE/LN. It 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 are important in the development of lupus. The participant’s modified T-cells are then put back into the person’s body.
Before giving the YTB323 CAR T-cell therapy, people often receive conditioning treatment to reduce the count of the type of blood cells called lymphocytes and improve the chances of this YTB323 CAR T-cell therapy working. The conditioning treatment used in this study includes two chemotherapy drugs, fludarabine and cyclophosphamide. This conditioning treatment will make room in the body for the participant’s modified YTB323 CAR T cells.
This trial has 2 parts. 45 participants are expected to join Part A and 99 participants are expected to join Part B. In Part A, participants will be randomly placed into 1 of 3 groups to receive either the study treatment YTB323 or the Standard of Care (SOC). In Part B, participants will be randomly placed into 1 of 2 groups to receive either the study treatment YTB323 or SOC. If SOC is insufficient after 1 year, participants will be offered YTB323 in another study.
Participants receiving TYB323 will be hospitalised to receive the infusion and will visit the trial site 24 times during the first year and 8 times during the second year. Participants will be in the study for up to 2 years and 2 months.REC name
North East - York Research Ethics Committee
REC reference
24/NE/0143
Date of REC Opinion
5 Sep 2024
REC opinion
Further Information Favourable Opinion