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.”

Daily beetroot juice may help support kidney health during pregnancy in women with chronic kidney disease, early research suggests.

Pregnancy puts additional strain on the kidneys. Around half of women with moderate to severe chronic kidney disease experience a decline in kidney function while pregnant.

Despite these risks, outcomes for pregnant women with the condition have changed little over the past 30 years.

Many medicines used to manage kidney disease are also unsuitable during pregnancy, meaning women often need to stop taking them for at least nine months.

Researchers at King’s College London examined whether dietary nitrate from beetroot juice could offer a simple and safe way to support kidney function during pregnancy.

Beetroot juice is naturally rich in nitrate, which the body converts into nitric oxide. Nitric oxide widens blood vessels and improves blood flow, which could reduce the strain placed on the kidneys during pregnancy.

The study involved 108 pregnant women with stage 2 to 5 chronic kidney disease across eight UK hospitals.

Before reaching 25 weeks of pregnancy, participants were randomly assigned to receive either standard care or a daily beetroot juice supplement containing dietary nitrate.

The study was mainly designed to assess whether a larger clinical trial would be practical. However, the findings also suggested possible benefits for mothers and babies.

Kate Bramham, consultant nephrologist at King’s College Hospital, professor at King’s College London and senior author of the study, said: “For women living with chronic kidney disease, pregnancy has always meant navigating a difficult trade-off between preserving their own health and keeping their baby safe, often with few tools to do both.

“These results are an encouraging first step towards a low-cost, low-risk intervention that could genuinely make a difference for this group of women, who have been underserved by research for far too long.”

Women receiving beetroot juice experienced around 70 per cent fewer serious adverse events overall than those receiving standard care. Of the serious adverse events that occurred, around half affected newborn babies.

Among women with more advanced kidney disease, researchers also observed trends towards better kidney function after pregnancy, fewer newborn admissions to neonatal care and a reduced need for blood pressure medication during pregnancy.

The researchers found no safety concerns linked to beetroot juice supplementation during pregnancy, including no increase in hyperkalaemia, which means unusually high potassium levels in the blood.

There have been concerns that beetroot juice could increase the risk of hyperkalaemia in pregnant women with chronic kidney disease, with some online advice recommending that they avoid it. However, no increase was recorded among women receiving the supplement.

Dr Priscilla Smith, a nephrologist, King’s College London PhD student and first author of the study, said: “Pregnancy can put additional stress on the kidneys, and for women with chronic kidney disease there are currently limited options to protect kidney function during this time.

“Our findings suggest beetroot juice could offer a simple and accessible approach that is safe and worth exploring further.”

The researchers said larger clinical trials are now needed to determine whether beetroot juice can significantly reduce kidney function decline and improve long-term outcomes for mothers and babies.

If confirmed, the intervention could offer an inexpensive and widely available way to support women with chronic kidney disease during pregnancy, when safe treatment options remain limited.

The research was supported by funding from Kidney Research UK.

Dr Andrew Webb, clinical senior lecturer at King’s College London and a co-author of the study, said: “By increasing nitric oxide production, dietary nitrate from beetroot juice may help improve blood vessel function and support kidney health.

“These early findings provide an important foundation for future research into protecting women with chronic kidney disease during pregnancy and their babies.”

Menstrual cycle timing may affect vaccine side effects, according to a study involving 1,474 users of period-tracking app, Clue.

People vaccinated before ovulation were more likely to report side effects than those vaccinated after ovulation.

They also appeared to go longer before a subsequent Covid-19 infection, although the researchers said this finding was exploratory.

Amanda Shea, fractional chief science officer at Clue, said: “We know that immune function fluctuates across the menstrual cycle, yet it’s still rarely considered in mainstream health research.

“To truly understand women’s health, we need to stop treating the menstrual cycle as background noise and start recognising it as a fundamental part of human biology.

“Incorporating cycle data into research is essential to building the evidence needed for more personalised and effective care.”

In the study, participants vaccinated during the follicular phase had 35 per cent higher odds of reporting any vaccine side effect than those vaccinated during the luteal phase.

The follicular phase occurs before ovulation, when oestrogen is dominant. The luteal phase follows ovulation and is dominated by progesterone.

Sensitivity analyses produced similar findings after people vaccinated around menstruation were excluded, suggesting the association was not simply explained by menstrual or premenstrual symptoms.

A sensitivity analysis checks whether findings remain consistent when researchers change parts of their analysis.

The researchers found no evidence that vaccination during the follicular phase was linked to more severe side effects or a greater number of side effects.

Those vaccinated during the follicular phase went a median of 35 days longer before reporting a subsequent Covid-19 infection.

The median was 200 days among those vaccinated during the follicular phase, compared with 164 days for those vaccinated during the luteal phase.

However, only 82 infections were recorded across the sample.

The researchers said the result was exploratory and intended to generate a hypothesis rather than provide evidence that vaccination timing improves protection.

The study was led by Poppy Cooper at the London School of Hygiene & Tropical Medicine and Alexandra Alvergne at the University of Montpellier.

They worked with researchers from Oregon Health & Science University and cycle-tracking company Clue.

The findings add to growing evidence that reproductive hormones may influence immune function.

Oestrogen is generally associated with heightened immune activity, while progesterone tends to have a dampening effect.

Previous studies have found that women often develop stronger antibody responses than men after vaccines for influenza, measles, mumps and rubella, and hepatitis. They also often report more side effects.

Antibodies are proteins made by the immune system that identify and help fight infections.

Clue said research has been central to its work since the company was founded.

Its users have tracked more than 250m cycles and contributed more than 30bn data points with their consent, creating what the company describes as one of the world’s largest long-term menstrual health datasets.

Clue works with researchers at institutions including MIT, Oxford, Columbia and the University of California, Berkeley.

The company said the study was possible because users chose to contribute their tracked cycle data to research.

Rhiannon White, chief executive of Clue, said: “Every time the Clue community tracks their cycle, they’re helping answer a question about their own body that medicine has too often ignored.

“This study is a small example of something bigger: when women are given the tools to understand themselves, and the research catches up to meet them, real change becomes possible.”

Researchers surveyed Clue users about when they received their first Covid-19 vaccine dose, any side effects they experienced and subsequent infections.

The responses were matched with cycle information that each participant had previously recorded in the app, rather than relying on recalled estimates.

Of the 1,474 users included, 760 were vaccinated during the follicular phase and 714 during the luteal phase.

The researchers stressed that people should not use the findings to schedule vaccinations around their menstrual cycle.

They said receiving a vaccine when it is available remains far more important than the phase of the cycle in which it is given.

As the first study to investigate the association, further evidence is needed before any recommendations can be made.

The researchers said future vaccine and immunology studies should consider menstrual cycle phase as an important variable.