Phase 1 Study of Allo-RevCAR01-T-CD123 in Patients With Selected CD123 Positive Hematologic Malignancies (1b Dose Expansion)
Sponsor: AvenCell Europe GmbH • ClinicalTrials.gov ID: NCT05949125
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Check Eligibility →Description
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.
Interventions
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Cyclophosphamide (Non-IMP, Lymphodepletion)
(Other)
Intravenous infusion over 3 days (d-5 to d-3)
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Fludarabine (Non-IMP, Lymphodepletion)
(Other)
Intravenous infusion over 3 days (d-5 to d-3)
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R-TM123
(Drug)
Intravenous infusion over 20 days
-
Allo-RevCAR01-T
(Drug)
Allo-RevCAR01-T will be administered as IV infusion on Treatment Day 1
Eligibility criteria
Conditions
Locations
- Universitätsklinikum Ulm — Ulm, Baden-Wurttemberg, Germany
- Klinikum der Universität München — Munich, Bavaria, Germany
- Universitätsklinikum Würzburg — Würzburg, Bavaria, Germany
- Universitätsklinikum Marburg — Marburg, Hesse, Germany
- Universitätsklinikum Dresden — Dresden, Saxony, Germany
- Charité Universitätsmedizin Berlin — Berlin, State of Berlin, Germany
- Universitätsklinikum Köln — Cologne, Germany
- Universitätsklinikum Essen — Essen, Germany
- Universitätsklinikum Frankfurt — Frankfurt, Germany
- Universitätsklinikum Hamburg-Eppendorf — Hamburg, Germany
- Medizinische Hochschule Hannover — Hanover, Germany
- Universitätsklinikum Heidelberg — Heidelberg, Germany
- Erasmus University Medical Center — Rotterdam, Gelderland, Netherlands
- Amsterdam University Medical Center — Amsterdam, HV, Netherlands
- University Medical Center Groningen (UMCG) — Groningen, RB Groningen, Netherlands
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Learn MoreOfficial Source
Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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