Ireland’s first-ever clinical study of CAR-T cell therapy for treating multiple myeloma opens
CARTITUDE-5 provides suitable newly diagnosed patients in Ireland with a new treatment option and is now recruiting patients
Ireland’s first ever clinical trial for a cell therapy to treat multiple myeloma, a type of blood cancer, is now open at St James’s Hospital, Dublin, where eligible study participants may access a new treatment option for myeloma. CARTITUDE-5, a multicentre global study, seeks to evaluate the efficacy and safety of CAR-T as a frontline therapy in people newly diagnosed with this rare form of blood cancer for whom a stem cell transplant is not planned as an initial treatment.1
Chimeric antigen receptor (CAR)-T cell therapy is a highly personalised technology whereby a patient’s own T-cells can be re-programmed to target and kill cancer cells. It involves collecting a type of white blood cells, called T-cells, from a patient’s blood and genetically altering them in a lab before transfusing them back into the patient to fight the cancer.2
Multiple myeloma is an incurable form of blood cancer that starts in the bone marrow, most commonly affecting people over the age of 65 and is more common in men than in women.3 It is the second most common blood cancer with approximately 2,200 people living with it in Ireland today and 352 people newly diagnosed annually.4 However, despite significant advances in treatment for multiple myeloma in recent years, high unmet need remains.5
Pictured L-R: Dr Paul Browne (Consultant Haematologist), Nicola Gardiner (Chief Medical Scientist), Dr Larry Bacon (Consultant Haematologist), Geraldine Walpole, (Chairperson of Multiple Myeloma Ireland), Dr Patrick Hayden (Consultant Haematologist)
CARTITUDE-5 is the first study to evaluate CAR-T as a frontline therapy in newly diagnosed patients. The trial is being led by Dr Larry Bacon, clinical lead for Ireland’s National Adult CAR-T Centre, located at St James’s Hospital. The study will be performed in collaboration with the Wellcome HRB Clinical Research Facility at St James’s Hospital which is providing specialised infrastructure, nursing and research pharmacy support.
Speaking about the launch of the study today, Dr Larry Bacon said: “The National Adult CAR-T Centre is spearheading the introduction of cell therapies, which are transforming how blood cancer is treated in Ireland. CAR-T therapy is a lifeline for blood cancer patients. Through the CARTITUDE-5 trial, we will offer suitable newly diagnosed multiple myeloma patients access to a potentially life saving CAR-T therapy. We look forward to delivering this specialised therapy to multiple myeloma patients as part of the trial.”
Professor Martina Hennessy, consultant clinical pharmacologist and Director of the Wellcome HRB Clinical Research facility at St James’s Hospital, said: “Access to clinical trials of novel and advanced therapies such as CAR-T are critical to generating new knowledge and changing the outcomes for patients with myeloma. While the outcome of any clinical trial is uncertain, we commend Irish patients and their families for their willingness to participate in this important work. St James’s Hospital has always played a major role in cancer clinical trials and this study is a natural evolution into a dynamic new era for cancer therapy”.
Dr Patrick Hayden, Consultant haematologist and clinical lead for the Myeloma Service at St James’s Hospital, said: “Cancer research is vital to improve the prevention, detection, and treatment of cancer. This trial represents a significant development for the treatment of multiple myeloma. CAR-T therapy has already demonstrated its ability to achieve very good responses among multiple myeloma patients at an advanced stage who have undergone multiple treatments previously. The CARTITUDE-5 study aims to assess whether outcomes could be improved by bringing CAR-T therapy forward in the patient’s myeloma experience rather than waiting until they are at an advanced stage. It’s great to bring this innovative cell therapy to Irish patients through this trial.”
Geraldine Walpole, Chairperson of Multiple Myeloma Ireland, said: “This is a welcome development for newly diagnosed multiple myeloma patients in Ireland. Participation in the CARTITUDE-5 clinical trial may provide access to a much-needed cutting-edge treatment option. We hope this trial will ultimately contribute towards better treatment regimens for patients living with multiple myeloma.”
This study has been made possible in Ireland thanks to a major collaboration between the Haematology, Oncology and Palliative Care (HOPe) Directorate and medical, nursing, cryobiology laboratory, pharmacy and corporate teams at St James’s Hospital and the Trinity St James’s Cancer Institute, along with industry, the Department of Health, HPRA and the NCCP.
The CARTITUDE-5 study is now open for enrolment and healthcare professionals should contact CARTITUDE-5Clinicaltrial@stjames.ie for queries regarding patient participation.
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