Trials / Terminated
TerminatedNCT04230265
Phase 1 Study of UniCAR02-T-CD123 in Patients With Selected CD123 Positive Hematologic Malignancies
Multicenter, Open-label, Adaptive Design Phase I Trial With Genetically Modified T-cells Carrying Universal Chimeric Antigen Receptors (UniCAR02-T) in Combination With CD123 Target Module (TM123) for the Treatment of Patients With Hematologic and Lymphatic Malignancies Positive for CD123
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- AvenCell Europe GmbH · Industry
- Sex
- All
- 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-CD123 in patients with hematologic and lymphatic malignancies positive for CD123 marker. The UniCAR02-T-CD123 drug is a combination of a cellular component (UniCAR02-T) with a recombinant antibody derivative (TM123) which together forms the active drug.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cyclophosphamide (Non-IMP) | Intravenous infusion over 3 days |
| DRUG | Fludarabine (Non-IMP) | Intravenous infusion over 3 days |
| DRUG | TM123 (IMP) | Intravenous Infusion for 20 days |
| DRUG | UniCAR02-T (IMP) | Intravenous infusion of single dose |
Timeline
- Start date
- 2020-01-28
- Primary completion
- 2025-04-11
- Completion
- 2025-04-11
- First posted
- 2020-01-18
- Last updated
- 2026-01-22
Locations
10 sites across 2 countries: Germany, Netherlands
Source: ClinicalTrials.gov record NCT04230265. Inclusion in this directory is not an endorsement.