NCT05949125

Phase 1 Study of Allo-RevCAR01-T-CD123 in Patients With Selected CD123 Positive Hematologic Malignancies

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: AvenCell Europe GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia, in Relapse
• Acute Myeloid Leukemia Refractory

Interventions

Type	Name	Description
OTHER	Cyclophosphamide (Non-IMP, Lymphodepletion)	Intravenous infusion over 3 days (d-5 to d-3)
OTHER	Fludarabine (Non-IMP, Lymphodepletion)	Intravenous infusion over 3 days (d-5 to d-3)
DRUG	R-TM123	Intravenous infusion over 20 days
DRUG	Allo-RevCAR01-T	Allo-RevCAR01-T will be administered as IV infusion on Treatment day 1.

Timeline

• Start date: 2024-01-03
• Primary completion: 2027-05-01
• Completion: 2028-01-01
• First posted: 2023-07-17
• Last updated: 2025-05-14

Locations

11 sites across 2 countries: Germany, Netherlands