Active Cancer NIHR-supported project Brain & Nervous System

A Phase 3, Randomized, Open-Label Study to Compare the Efficacy and Safety of Anitocabtagene Autoleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Multiple Myeloma

Funder NIHR (part of DHSC)
Recipient organisation NIHR Bristol Clinical Research Facility
NIHR support Recorded as supported by this research centre
Period Mar 2025 — Jul 2031

In plain English

AI plain-English summary

A single infusion of a patient’s own genetically modified immune cells is being tested against standard chemotherapy combinations for multiple myeloma that has stopped responding to treatment. Multiple myeloma, a cancer of plasma cells in the bone marrow, often returns or becomes resistant to therapy. Current treatments then offer limited benefit. This phase 3 trial will enroll roughly 450 patients worldwide, randomly assigning half to receive anitocabtagene autoleucel (anito-cel) — a CAR-T therapy made from the patient’s own T-cells reprogrammed to recognise and kill myeloma cells — and half to receive one of four standard chemo-immunotherapy regimens. Patients will be followed for about four years. If anito-cel proves more effective than standard care, it could offer a durable, one-time treatment option for patients with relapsed or refractory multiple myeloma, reducing the need for repeated chemotherapy cycles and their cumulative side effects. The trial will also generate safety data needed for regulatory approval, potentially expanding access to CAR-T therapy for a broader group of myeloma patients.

View original technical description
Multiple myeloma is a cancer that forms in a type of white blood cell called a plasma cell. In multiple myeloma, cancerous plasma cells build up in bone marrow. This can affect multiple areas of the body including the spine, pelvis and ribs. Symptoms include bone pain, tiredness and kidney problems. This study is for relapsed or refractory multiple myeloma, which means that the cancer has returned or is non-responsive to current treatment. The aim of this study is to find out if the experimental treatment, anitocabtagene autoleucel (anito-cel), is safe and effective in treating relapsed or refractory multiple myeloma compared to standard of care treatment (SOCT). Anito-cel is made by using a type of the participant’s own white blood cells, called T-cells. The cells are collected, changed to target the participant’s cancer cells, and given back to them. The study will involve approximately 450 participants globally. It has 2 treatment groups: • Anito-cel - involves collection of white blood cells to manufacture anito-cel, 3 days of lymphodepleting chemotherapy to prepare for receiving of anito-cel, and then a single infusion of anito-cel. • SOCT – involves receiving 1 of 4 chemo-immunotherapy based therapies available to treat multiple myeloma.Participants will be randomly assigned to one of the treatment groups by a process called randomisation and they will have a 50% chance of being in the Anito-cel Group. Both the participant and their doctor will know which group they have been assigned to.The duration of the study may be different for each participant as it will depend on things like which treatment group they are assigned to and the response to the therapy. Participants from both groups will be followed on the study for approximately 4 years. Participants will attend their study site for visits over this period. These visits will involve procedures such as physical exams, blood samples, biopsies and scans.

Researchers

James Griffin (Principal Investigator)

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