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

NCT05949125 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-05-14

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Allucent (NL) BV

    collaborator UNKNOWN

  • AvenCell Europe GmbH

    lead INDUSTRY

Principal Investigators

  • Tapan Maniar, MD · AvenCell Europe GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-03
Primary Completion
2027-05-31
Completion
2028-01-31

Countries

  • Germany
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05949125 on ClinicalTrials.gov