Trials / Terminated
TerminatedNCT04633148
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
Multicenter, Open-label, Adaptive Design Phase I Trial With Genetically Modified T-cells Carrying Universal Chimeric Antigen Receptors (UniCAR02-T) in Combination With PSMA Peptide Target Module (TMpPSMA) for the Treatment of Patients With Progressive Disease After Standard Systemic Therapy in Cancers With Positive PSMA Marker
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- AvenCell Europe GmbH · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cyclophosphamide (Non-IMP) | Intravenous infusion for 3 days |
| DRUG | Fludarabine (Non-IMP) | Intravenous infusion for 3 days |
| DRUG | UniCAR02-T-pPSMA | Intravenous Infusion for 21 days |
| DRUG | UniCAR02-T (IMP) | Intravenous infusion of single dose |
Timeline
- Start date
- 2020-11-23
- Primary completion
- 2024-03-28
- Completion
- 2024-03-28
- First posted
- 2020-11-18
- Last updated
- 2024-04-23
Locations
4 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT04633148. Inclusion in this directory is not an endorsement.