Health Trials

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

ConditionsAcute Myeloid Leukemia, in RelapseAcute Myeloid Leukemia Refractory
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAvenCell Europe GmbH

About this trial

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.

Eligibility criteria

Qualifiers

For Phase 1a escalation part of the trial Participants with CD123+ AML (defined as ≥20% of leukemic cells expressing CD123 at any point in the course of disease)

For Phase 1b expansion part of the trial (Phase 1b) Participants with CD123+ AML (defined as ≥20% of leukemic cells expressing CD123 at any point in the course of disease)

up to 3rd relapse for whom all standard or life-extending therapies have failed and for whom no potentially curative therapies are available or who are intolerant to such therapies

having up to 30% blasts in a bone marrow assessment at either screening or prescreening, or having between 30% and 40% blasts for two consecutive bone marrow assessments with a minimum of one month and no more than two months apart,

Disqualifiers

Acute promyelocytic leukemia (t15;17).

AML with only extramedullary manifestations (e.g., chloroma, primary myeloid sarcoma)

Acute manifestationof AML in the central nervous system.

Bone marrow failure syndromes

Trial design

Treatments tested in this trial

  • Cyclophosphamide (Non-IMP, Lymphodepletion)
  • Fludarabine (Non-IMP, Lymphodepletion)
  • R-TM123
  • Allo-RevCAR01-T

Treatment groups

80 Participants
are divided into 1 treatment group

Sponsors and collaborators

AvenCell Europe GmbH

Lead sponsor

Allucent (NL) BV

Collaborator

Source ClinicalTrials.gov