We have an ethics-approved protocol within Peter Mac to look retrospectively at infection outcomes that will cover compassionate access bispecifics if sites remain interested. Long story short, the original protocol for infections in CAR-T patients that we have been running for 2 years now also included approval for bispecific patients, under a banner of infections in cellular therapies patients. We just never activated that bispecifics arm. The criterion for approval was either a) not on trial e.g. compassionate access or b) on trial but with PI approval of the trial + of the site. We are not seeking to collect infection outcomes in trials-treated patients.

It follows for sites already involved in the CAR-T study, involvement could be as (hopefully) straightforward an amendment to the DTA (this would cover RPA, RBWH, Fiona Stanley, Alfred) to expand out to bispecific compassionate access patients (because the infection protocol covered both CAR-T and bispecifics initially, but we pursued CAR-T SOC preferentially)

Timeline would be:2nd half of this clinical year for set-up, and then data entry thereafter. If sites are interested, perhaps they could express this to Mary Ann and we’ll contact them more individually. 29/7/25 – Gemma writing her thesis at the moment. Still some months away.

9/10/25 – onhold for now