Trials and tribulations

In December 2021 I heard that an exciting clinical trial for progressive MS was enrolling participants again. ATA188 was the work of Professor Michael Pender at the University of Queensland, a study I’d been following for years. In fact I’d enquired about taking part in the Phase 1 trial about 12 years ago, but it would have required weekly visits to the trial centre in Brisbane. The Mechanic and I discussed the possibility of moving to Brisbane for a year, but only briefly.

Pender was looking at the increasingly viable prospect that MS was largely caused by Epstein Barr virus. EBV causes glandular fever – a week or two of sore throat, swollen glands, fever and fatigue. The virus is usually eradicated quickly by the immune system. Usually. But if remnant infected cells remain, they can stay dormant for years then re-emerge to attack healthy nerve cells.

If you want more science, here’s a good plain-English wrap.

ATA188 is a cell line that targets those remnant, EBV-infected cells and clears them to allow nerve cells to heal. Trial participants are seeing improvements in their condition – in the world of progressive MS, this was more than we’d ever been led to hope for.

Now the study is in Phase 2 – safety and efficacy. I checked the current inclusion criteria: under 61 years, progressive MS, still walking, not on any disease-modifying drugs … I seemed to tick all the boxes. And there was now a trial centre in Sydney, at Liverpool Hospital. There were another 20 or so in the US and Canada – Pender’s work has now gained global attention.

I immediately made a Zoom appointment with my neurologist. He skimmed through the ATA188 web page and agreed with me – I qualified. ‘Ah,’ he said, ‘the lead investigator at Liverpool is Suzanne Hodgkinson. I know her, I’ll call her now.’

So he picked up his phone, infuriatingly (but understandably) muted himself, and for the next ten minutes I stared at a window on my computer screen while my neuro had an animated but silent conversation with someone who might well be about to change my life. At last he put his phone down and unmuted himself.

‘She says that you’re looking good. The only question is your mobility. She said, “If she can stagger 20 metres on a walker, I’ll take her.”‘

‘I’ll stagger any number of metres she wants!’ I said.

In early March I was being pre-screened in the Neurology Department at Liverpool Hospital. I watched as the trial nurse checked boxes on a form. Age? Tick. Previous Epstein Barr infection? Tick. No disease modifying treatment in progress? Tick. Tick, tick, tick. A brush with melanoma in 2005 came up and her pen hovered above the page … but the mole excised, five lymph nodes removed, tested and clear … she smiled. ‘That shouldn’t be a problem.’

That afternoon I met Suzanne Hodgkinson, a slim, taut bundle of energy. She seemed to jog everywhere she went. She took notes on page after page of blank paper, drawing diagrams for me as she went. We discussed the melanoma; again that brief pause, then, ‘Shouldn’t be a problem.’

In late March I was in Liverpool again for further screening. A physical examination with a nurse practitioner to determine the state of my MS – I scraped in with an EDSS score of 6.5, ie still ambulant, albeit with a wheelie walker. Blood samples taken to be sent to various global labs for more testing. An interview with another neurologist and the signing of form after form after form.

Two weeks later, a call from the trial nurse: the blood results were back, all good. I was in. She booked me for the next visit, late April: a day of baseline testing (that 20-metre stagger, etc) then, the next day, my first infusion.

Trial participation would require six more visits to Sydney in the next eight weeks, a prospect I was prepared to entertain for the purpose of the trial, but one the Mechanic relished – he’d been cooped up for two years with hardly a chance to get on the highway.

Did I ever mention that this was the man who sobbed through his vows on our wedding day, and, when the celebrant asked, ‘Will you take this woman …’, he said, ‘Yes, please!’

Gratitude. I’d been experiencing random flushes of gratitude for a while, and not just for the Mechanic. A surge for that dappled sweep of highway coming home from Bega, where the road leaves farmland to track the river, canopied and lush, and hooks down to the Brogo Bridge. A rush of thanks for that little dropper bottle of cannabis oil for my night-time muscle spasms. For a home that didn’t burn down on that horror night three New Year’s Eves ago. A wave of gratitude for a federal electorate that voted for change in May. For our beds of red hot pokers that burst into flower in early winter, when the only other colour in the garden is ripening oranges and remnant red liquidambar leaves. And the noisy miners who clamber around the poker stems to sip beads of nectar from the flutes.

Anyway, the call came as we were packing for that next Sydney trip, for my first infusion. The trial nurse. At the eleventh hour I’d been excluded – it was the melanoma, after all, no matter how improbable its return. The trial sponsors in the US were nervous; a recurring melanoma would not help their FDA approval. Two months of hope, of allowing myself the prospect of a not-so-bleak future, dashed.

Yes, I appealed the decision. Seventeen years melanoma-free, those cancer-free lymph nodes, a specialist prepared to put in writing that the chance of a recurrence was vanishingly small. No dice. Emails, phone calls, hours scouring the web to learn more about trial protocols and exclusion criteria and ethics committees than I ever thought I’d need.

Three months later I’ve exhausted all avenues of appeal. There’s a chance I could join the Phase 3 trial in October 2023 – that’s if I can still stagger twenty metres by then. But still, the gratitude. Gratitude that with or without me the ATA188 trial is going ahead and an effective treatment for progressive MS is in the pipeline.