Obe-cel as 1L consolidation therapy for LBCL patients in CMR and MRD+
Research type
Research Study
Full title
A Phase 3, Multicenter, Randomized, Open-Label Study Comparing the Efficacy and Safety of Obecabtagene Autoleucel Consolidation Versus Observation at End of First-line Treatment in MRD Positive Patients with Large B Cell Lymphoma
IRAS ID
1012369
Contact name
Nirav Patel
Contact email
Sponsor organisation
Autolus Limited UK
Eudract number
2024-519689-39
Research summary
Researchers are looking for a way to treat a blood cancer called large B cell lymphoma (LBCL). LBCL happens when a type of white blood cell, called a B cell, grows too much and forms tumours (lumps). In healthy people, B cells grow normally and help the immune system to keep you well.
Standard (usual) treatments given to people with LBCL will kill B cells and scans may show that the cancer is gone. For some people, a small amount of cancer cells may remain in the body and may cause cancer to come back. This is called measurable residual disease (MRD).
In this trial, researchers are testing a new treatment called obe-cel. Obe-cel is made in the laboratory using another type of white blood cell, called T cells. These T cells are collected from the same person who will be receiving obe cel (a method called leukapheresis).
This trial will test obe-cel treatment in participants with LBCL whose scans show no signs of cancer after their usual LBCL treatment and who also have positive MRD status, which is found by a blood test (also known as a liquid biopsy). In this trial, we will use the investigational diagnostic test, clonoSEQ plasma MRD assay (Adaptive Biotechnologies). The goal of obe-cel treatment is to kill B cells and any remaining cancer cells to lower the chances of cancer coming back and to keep the participant cancer-free for a longer time.This is an open-label, randomised trial. Participants who are a good fit for the trial will be randomised to either the “obe-cel consolidation” group (where they will receive obe-cel), or to the “observation” group (where they will not receive obe-cel and will be monitored in the same way as usual). In the first 28 days after obe-cel treatment, the participant’s temperature will be checked every day. All participants will have regular checkups, blood tests, and scans for up to 2 years. After 2 years, participants receive usual medical care and blood tests (including MRD) until the trial ends ).
REC name
London - West London & GTAC Research Ethics Committee
REC reference
25/LO/0689
Date of REC Opinion
30 Oct 2025
REC opinion
Further Information Favourable Opinion