PSMA/PSCA CAR-T China

[NickJoy]

I just wondered if there was anyone out there who knows how this trial is going? It looks very interesting and the study completion date is next year.

clinicaltrials.gov/ct2/show...

[tango65]

I do not know how this trial is doing but you could apply to these trials in the USA:

clinicaltrials.gov/ct2/resu...

clinicaltrials.gov/ct2/show...

There is some preliminary info about these treatments.

onclive.com/view/p-psma-101...

[NickJoy in reply to tango65]

Thank you.

[NJWarrior]

Previously, in August 2020, the FDA placed a clinical hold on the P-PSMA-101-001 trial following notification of a patient death.5 The patient had previously progressed on various anticancer therapies prior to receiving treatment with the CAR T-cell product in late July 2020 and was reported to have had normal laboratory results after the first week of treatment; at that time point, no clinical symptoms indicative of an adverse effect (AE) were reported.

The patient, however, went on to miss his follow-up visits that were scheduled for days 10 and 14. During that time, the patient went on to experience symptoms that resulted in hospitalization. On day 19 following treatment with the CAR T-cell product, the patient died of hepatic failure. The direct cause of the hepatic failure had not been confirmed.

Specifically, the patient had presented with symptoms that proved to be consistent with macrophage activation syndrome (MAS), which is a serious overactivation of the immune system that has previously been associated with CAR T-cell products. However, MAS can also be caused by other events like autoimmune disease or infection. The patient also experienced blurred vision and had a diagnosis of uveitis. The severe toxicity was found to potentially be linked with P-PSMA-101 but warranted further investigation.

onclive.com/view/p-psma-101...

[NickJoy in reply to NJWarrior]

Thank you.

[NickJoy]

It looks like the China research may be a little ahead of the research in USA in that they have already combined two targets - it would be nice to see them add a third target for neuroendocrine cells. I hope the results are good.