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A woman with advanced ovarian cancer has become the first patient globally to receive an experimental off-the-shelf cell therapy.
Tracy Tomlinson, 58, was given the experimental drug ZI-MA4-1 at the Christie NHS Foundation Trust in Manchester.
The treatment forms part of a clinical trial evaluating its use against several cancer types, including ovarian, lung, head and neck cancers and sarcomas.
The Christie is leading the trial, with a second site at the Royal Marsden in London. It involves patients with advanced cancers who may have few other treatment options.
Tomlinson, from Chadderton in Greater Manchester, has undergone surgery and multiple rounds of chemotherapy since she was diagnosed in 2020.
She said: “They’ve got rid of the cancer twice but then it came back about two and a half years ago, and we’ve never seemed to get rid of it since then.
“The chemotherapy has shrunk it but when treatment stops, it has come back.
“It is a lot to live with and there’s been ups and downs – there’s been elation, there’s been disappointment, and bits in between.
“But I try very, very hard to remain very positive. Every day that I wake up is a positive. You’ve got to have hope.”
ZI-MA4-1 combines two approaches to cancer treatment.
It uses natural killer cells, known as NK cells, which are specialist immune cells that identify and destroy abnormal cells.
T-cell receptors on the donor cells are also engineered to recognise and target tumours producing a protein called Mage-A4.
Mage-A4 is found in several types of cancer and is considered by experts to be a potential target for attacking abnormal cells.
Unlike personalised treatments, ZI-MA4-1 is designed as an off-the-shelf therapy using immune cells from donors.
The treatment is manufactured in advance rather than being made separately for each patient, with hundreds of doses potentially produced from one manufacturing batch.
Experts believe this approach could make advanced cell therapies available to more patients, more quickly and at a lower cost.
Tomlinson was diagnosed with ovarian cancer that had spread shortly before Christmas 2020 and began treatment immediately.
By summer 2021, scans showed no evidence of disease, but the cancer returned around a year later.
Despite further treatment and 48 chemotherapy infusions, the cancer continued to return.
The former Civil Service manager was diagnosed with stage 3C ovarian cancer, meaning cancer growths had spread into the peritoneum, the tissue lining the abdominal cavity.
She currently has a tumour between her liver and kidney, as well as smaller tumours elsewhere.
She said: “They’ve got rid of the cancer twice but then it came back about two and a half years ago, and we’ve never seemed to get rid of it since then.
“The chemotherapy has shrunk it but when treatment stops, it has come back.
“It is a lot to live with and there’s been ups and downs – there’s been elation, there’s been disappointment, and bits in between.
“But I try very, very hard to remain very positive. Every day that I wake up is a positive. You’ve got to have hope.”
Tomlinson said she had been target-driven during her working life and had set herself high standards.
“But you can’t control cancer,” she said. “What I can control is how I look at it, how I deal with it, and trying to eat healthily and taking the positives in everything.
“And I’ve learned to appreciate the smallest of things that we take for granted – and the people around you and what they mean to you.
“Also, the beauty of outside and the trees and the colour of the trees and the birds singing.
“We just go from A to B, don’t we? Busy, busy, busy. But we never slow down and take in the wonder of what’s around us.
“I often think, ‘I’m still here’, and that’s helped me think, ‘Why can’t I still be here in 10 years?’, ‘Why can’t I still be here in 15 years?’
“And I believe taking all the treatments offered to me is helping me kick that can a bit further down the road.
“I don’t want to go anywhere. I’ve still got a lot of things I want to do and things I want to achieve.”
Tomlinson said her husband Paul, whom she married in 2022, is her “rock”. She is also close to her son Harry, 28.
Last year, she was referred to the Christie’s early-phase clinical trials team for extensive screening and learned she was eligible for the Zima-101 clinical trial.
She said: “I decided almost straight away that I was going to go for it.
“Then afterwards you think, ‘Am I doing the right thing?’, because it is a little bit scary being the first person in the world to have the treatment.”
She has received three infusions of the therapy, with the option of a fourth depending on her scan results.
She said: “If it benefits me, absolutely fantastic. But if it benefits other people in the future, that’s important too.
“I don’t want to have gone through everything I’ve gone through for nothing. I want to feel like I have made a difference.”
Professor Fiona Thistlethwaite, consultant medical oncologist at the Christie, said: “While this is an early-stage study primarily focused on safety, it represents an exciting step forward in efforts to develop new treatment options for people like Tracy with advanced solid tumours.
“We hope the knowledge gained will help shape future cancer treatments and ultimately improve outcomes for patients.”
Dr Jon Lim, consultant medical oncologist in advanced immunotherapy and cell therapy at the Christie, told PA: “What’s very exciting about this is that these are essentially not kind of antibody-based, but living cells.
“These are live immune cells that are infused in hundreds of millions back to the patient, and the idea of this is that it is a little bit more targeted.
“The reason this is very interesting is because this is the first of its kind globally in this approach, where it’s taking donor immune cells, manipulating or engineering them, and putting them into the recipient.
“Tracy is essentially getting somebody else’s immune cells that have been engineered to ‘see’ her cancer.
“We’re very excited. This is a novel approach in the cell therapy space. We are also really showcasing what we can do in the UK.”
Namir Hassan, chief executive of Norwegian company Zelluna, which makes ZI-MA4-1, described Tomlinson’s first dose as a “landmark moment”.
He said: “It represents the moment when years of research moved beyond the laboratory and into the clinic, offering a new potential treatment option for patients facing advanced cancers with limited alternatives.”
Only around 15 per cent of women survive ovarian cancer for five years or more after diagnosis.
Dr Diana Hernandez, director of immune and advanced therapies at Anthony Nolan, said: “NK cells have huge potential as off-the-shelf therapies, and this trial takes us one step closer to a wider application of engineered NK cells in the targeted treatment of cancers.”
