Phase 1 Study of UniCAR02-T-CD123 in Patients With Selected CD123 Positive Hematologic Malignancies

Phase 1 Terminated 32 enrolled AvenCell Europe GmbH PHARMALOG Institut für klinische Forschung GmbH · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2020-01-28
Primary completion: 2025-04-11
Completion: 2025-04-11

Outcome

Outcome not reported

Stopped (Business): “business decision by sponsor”

Publications

Loff S, Dietrich J, Meyer JE, Riewaldt J, Spehr J, von Bonin M, Grunder C, Swayampakula M, Franke K, Feldmann A, Bachmann M, Ehninger G, Ehninger A, Cartellieri M. Rapidly Switchable Universal CAR-T Cells for Treatment of CD123-Positive Leukemia. Mol Ther Oncolytics. 2020 Apr 29;17:408-420. doi: 10.1016/j.omto.2020.04.009. eCollection 2020 Jun 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TM123	Protein / enzyme biologic	4 mg	Intravenous
Subject	TM123	Protein / enzyme biologic	8 mg	Intravenous
Subject	UniCAR02-T	Cell therapy	—	Intravenous
Background	Cyclophosphamide	Other / unclassified	—	Intravenous
Background	Fludarabine	Small molecule	—	Intravenous