Dose-escalating Trial With UniCAR02-T Cells and PSMA Target Module (TMpPSMA) in Patients With Progressive Disease After Standard Systemic Therapy in Cancers With Positive PSMA Marker
Summary
This dose-escalating phase I trial assesses for the first time the safety, the side effects and the harmlessness, as well as the therapeutical benefit of the new study drug UniCAR02-T-pPSMA in patients with progressive disease after standard systemic therapy in castration-resistant prostate cancers with positive PSMA marker. The UniCAR02-T-pPSMA drug is a combination of a cellular component (UniCAR02-T) with a recombinant antibody derivative (TMpPSMA) which together forms the active drug.
Timeline
- Start
- 2020-11-23
- Primary completion
- 2024-03-28
- Completion
- 2024-03-28
Outcome
Outcome not reported
Stopped: “Although IMP has been well tolerated, biological activity was very limited. The sponsor concluded that continued development of IMP would be unlikely to result in meaningful clinical benefit for patients with prostate cancer.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | UniCAR02-T-pPSMA | Other / unclassified | — | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Fludarabine | Small molecule | — | Intravenous |
| Background | UniCAR02-T | Cell therapy | — | Intravenous |