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Brief Title: Dose-escalating Trial With Allo-RevCAR01-T Cells in Combination With CD123 Target Module (R-TM123) for Participants With Selected Hematologic Malignancies Positive for CD123
Official Title: Multicenter, Open-label, Phase 1 Study of Allo-RevCAR01-T-CD123 Consisting of Genetically Modified T Cells Carrying Reverse Chimeric Antigen Receptors (Allo RevCAR01 T) in Combination With CD123 Target Module (R-TM123) for the Treatment of Patients With Selected Hematologic Malignancies Positive for CD123
Study ID: NCT05949125
Brief Summary: The Allo-RevCAR01-T-CD123 drug is a combination of a cellular component (Allo-RevCAR01-T) with a recombinant antibody derivative (R-TM123), which together form the active drug. The cellular component Allo-RevCAR01-T consists of an allogeneic human T-cell genetically multi-edited and expressing a reversed, universal chimeric antigen receptor (RevCAR) presenting an extracellular peptide epitope (RevCAR epitope). R TM123 functions as a bridging module between Allo RevCAR01-T and a CD123-expressing target cancer cell by selectively binding the RevCAR epitope and CD123.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Universitätsklinikum Ulm, Ulm, Baden-Württemberg, Germany
Klinikum der Universität München, Munich, Bavaria, Germany
Universitätsklinikum Würzburg, Würzburg, Bayern, Germany
Universitätsklinikum Marburg, Marburg, Hessen, Germany
Universitätsklinikum Dresden, Dresden, Sachsen, Germany
Charité Universitätsmedizin Berlin, Berlin, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Universitätsklinikum Köln, Köln, , Germany
Erasmus University Medical Center, Rotterdam, GD, Netherlands
Amsterdam University Medical Center, Amsterdam, HV, Netherlands
University Medical Center Groningen (UMCG), Groningen, RB Groningen, Netherlands
Name: Tapan Maniar, MD
Affiliation: AvenCell Europe GmbH
Role: STUDY_DIRECTOR