Clinical Trial

Disease: Relapsed or Refractory Acute Myeloid Leukaemia, AML, (NCT05949125)

Disease info:

Leukaemia is cancer of the white blood cells which are responsible for fighting infection. In leukaemia, the bone marrow produces abnormal levels of white blood cells. Acute myeloid leukaemia (AML) starts in the bone marrow but often quickly spreads into the bloodstream. AML sometimes spreads to other parts of the body such as the lymph nodes, liver, central nervous system and testicles. 

Commonly, AML develops from cells other than lymphocytes that would normally develop into white blood cells. The World Health Organization (WHO) divides AML into several subtypes based off genetic association. AML is also known as acute myelocytic leukaemia, acute myelogenous leukaemia, acute granulocytic leukaemia, and acute non-lymphocytic leukaemia.

Relapsed AML refers to when a  patient had active treatment, went off treatment and then the disease came back. Refractory AML refers to as disease that is progressing despite active treatment.


The American Cancer Society estimates approximately 20,380 cases of AML will be diagnosed in the U.S. in 2023, and approximately 11,310 deaths. AML is predominantly found in adults and is one of the most common types of leukaemia in adults.
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


Name: Martina Raupach

Phone: +493514466450




Name: Katja Jersemann, Dr.

Phone: +493514466450



AvenCell Europe GmbH





Universitätsklinikum Ulm, Ulm, Baden-Württemberg, Germany, 89081

Universitätsklinikum Würzburg, Würzburg, Bayern, Germany, 97080

Universitätsklinikum Marburg, Marburg, Hessen, Germany, 35032

Universitätsklinikum Dresden, Dresden, Sachsen, Germany, 01307

Charité Universitätsmedizin Berlin, Berlin, Germany, 13353

Medizinische Hochschule Hannover, Hannover, Germany

Universitätsklinikum Köln, Köln, Germany, 50937

Study start:
Aug. 1, 2023
37 participants
Gene editing method:
Type of edit:
The cells are engineered with CRISPR/Cas9 to avoid graft versus host disease (GvHD) and rejection via the host/patient immune system by either innate or adaptive mechanisms.
Delivery method:
Undisclosed - Ex-vivo
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting


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.

Last updated: Mar. 8, 2024
Source: US National Institutes of Health (NIH)
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