CYTB323K12201: Phase II study of YTB323 vs rituximab in dcss
Research type
Research Study
Full title
A Phase II, multi-part, three-year, randomized, open-label, assessor-blinded, active-controlled, multicenter study to evaluate the efficacy and safety of rapcabtagene autoleucel versus rituximab treatment in participants with severe refractory diffuse cutaneous systemic sclerosis
IRAS ID
1009383
Contact name
Léa Dusuel
Contact email
Sponsor organisation
Novartis Pharma AG
Clinicaltrials.gov Identifier
Research summary
The purpose of this trial is to learn about the effect of YTB323 compared with rituximab in people
with difficult to treat severe diffuse cutaneous systemic sclerosis (dcSSc).leading to organ failure and may lead to death. YTB323 is being tested for its effects on dcSSc. 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, and 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 trial 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. 6 participants are expected to join Part 1 and 80 participants are
expected to join Part 2.
The main questions this trial aims to answer are:
• How many participants show a response at Week 52 after receiving a single
dose of YTB323?
A response is based on the assessment of end organ worsening and
improvement in skin thickening, lung function, and quality of life.
• What adverse events are reported during the trial?
An adverse event is any sign or symptom that participants have during a trial. Adverse events may or may not be caused by treatments in the trial.Before treatment researchers will check the participants’ health to confirm if they can take part in this
trial. During treatment and follow up for part 1, participants will receive YTB323 infusion directly into a vein once after receiving the conditioning treatment. For part 2, participants will receive either YTB323 or rituximab infusion directly into the vein after receiving the conditioning treatment.REC name
London - West London & GTAC Research Ethics Committee
REC reference
24/LO/0306
Date of REC Opinion
9 Aug 2024
REC opinion
Further Information Favourable Opinion