First patient treated in “our own” CAR T-cell therapy trial
19 February 2026
A first-in-human clinical trial to assess an experimental CAR T-cell therapy, fully developed by Peter Mac and manufactured onsite by Cell Therapies, has treated its milestone first patient.
The PLATYPS trial brings together the drug development and clinical expertise of Peter Mac and the highly specialised manufacturing capabilities of Cell Therapies, which is co-located in the same building.
This Phase I trial is assessing the CAR T-cell therapy PMCC-COE19 in eligible patients with CD19-expressing blood cancers, such as diffuse large B-cell lymphoma and B-cell acute lymphoblastic leukemia.
Enrolled patients are no longer responding to standard treatments and are not eligible for other CAR T-cell treatments. Each will receive a single infusion of PMCC-COE19 and will be monitored over time to assess response and side-effects.
The first of 12 patients has been infused, and preparations are underway to treat the second patient imminently.
Prof Simon Harrison
Peter Mac’s Centre of Excellence in Cellular Immunotherapy has advanced PMCC-COE19 from laboratory bench to patient bedside, including product manufacture and Therapeutics Goods Administration (TGA) approval to proceed to evaluation in a clinical trial.
Centre of Excellence in Cellular Immunotherapy Director, Professor Simon Harrison, says: “For over a decade, Peter Mac has led the way in both the clinical application and regional manufacture of CAR T-cell therapy - a groundbreaking treatment that can save the lives of patients with aggressive blood cancers”.
“We are now proud to reach this critical milestone of treating the first patient with PMCC-COE19 - our own CAR T-cell therapy - and which, through the GMP (Good Manufacturing Practice) capabilities and highest quality standards of our manufacturing partners at Cell Therapies, can be manufactured within our building.
“This milestone reflects the dedication and collaboration of an extraordinary team both at Peter Mac and Cell Therapies, and whose efforts are bringing us closer to offering this, and other innovative cellular immunotherapies, to more patients in need.”
Cell Therapies is Australia’s largest GMP-licensed manufacturing facility focused exclusively on cell therapies, and the clinical doses of PMCC-COE19 are being manufactured within its specialised clean lab facilities co-located in the same building as Peter Mac.
Cell Therapies produces high‑quality cell‑based products to support clinical trials. The organisation also has experience in the commercial supply of leading‑edge therapies to patients in Australia and across the region.
Dr Bev Menner
Cell Therapies CEO Dr Bev Menner says: “Our team is delighted to see the initiation of this first clinical trial based on an in-house product from the Centre of Excellence in Cellular Immunotherapy, a novel IP accelerator platform”.
“Together, we are bringing research, clinical, and manufacturing expertise into one partnership to drive the translation and commercialisation of innovative Australian IP to the clinic, enabling patient access to therapies that have the potential to be truly game-changing.”
CAR T-cell therapy has been a game-changer in the treatment of certain blood cancers. The treatment involves first collecting T-cells from the patient’s blood and modifying these cells to make them recognise the patient’s cancer.
The CAR T-cells are then infused into the patient, where they attack cancer cells, multiply and expand, and can provide ongoing protection by living in the patient’s blood.
Several CAR T-cell therapy products are approved for use in Australian patients against certain blood cancers, however PMCC-COE19 represents an exciting advance, as this product is developed and manufactured by an Australian team to provide an alternative option for patients.
Haematologist Dr Katherine Cummins will oversee the PLATYPS trial as the principal investigator.
PMCC-COE19 is the second in a pipeline of CAR T-Cell therapies to be fully developed and manufactured under one roof in Australia. Several other new CAR T-cell therapies are in development by Peter Mac, including novel CAR T-cells for a range of both blood and solid organ cancers.
This is being led by the Centre’s Chief Scientist, Prof Jane Oliaro, and Manufacturing and Development Manager, Dr Jessica Li. It is hoped that these CAR T-cell products will also soon receive approval from the TGA, which will allow more clinical trials to open later in 2026 and beyond.
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Contacts:
For more information contact the Peter Mac Communications team on 0417 123 048.
About Peter Mac
Peter MacCallum Cancer Centre is a world leading cancer research, education and treatment centre and Australia’s only public health service dedicated to caring for people affected by cancer.
About Cell Therapies
Cell Therapies Pty Ltd (Cell Therapies) is a contract development and manufacturing organization (CDMO) that manufactures and deploys advanced cell-based therapies to the global market. Established in 2003, Cell Therapies is one of the most experienced GMP compliant manufacturers for cell therapies, gene therapies, cellular immunotherapies, and regenerative medicine products globally. Working closely with its clinical and research collaborators at the Peter MacCallum Cancer Centre, Cell Therapies provides its clients with solutions for process development, GMP manufacturing, analytical development, cryopreservation, quality management, regulatory submission, and clinical trial support. Cell Therapies has a thirteen (13)-clean room GMP facility located in Melbourne, Australia at the heart of the Melbourne Biomedical Precinct with access to hospitals, research institutes and universities to support development, translation, and patient access. This facility includes three (3) commercial-scale high throughput manufacturing suites with a production capacity of up to 2,000 patient doses per year, and ten (10) small-scale clean rooms suitable for early phase clinical trials. Cell Therapies holds both clinical trial and commercial supply manufacturing licenses from the Australian Therapeutic Goods Administration (TGA), along with GMP manufacturing accreditation from the Japanese Ministry of Health, Labour, and Welfare, ensuring the products from our facility meet global regulatory standards. With a proven track record of delivering cell-based therapies to patients, Cell Therapies supports early phase clinical trials through to commercial supply according to the requirements of local and international regulators. Cell Therapies’ collaborative networks support product delivery all over the world and have an enviable track record for efficient and successful tech transfer for our collaborators and clients. To learn more about Cell Therapies, please click here: https://celltherapies.com/