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Phase 1 Study of UniCAR02-T-CD123 in Patients With Selected CD123 Positive Hematologic Malignancies

NCT04230265 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-01-22

No results posted yet for this study

Summary

This dose-escalating phase I trial assesses for the first time the safety, the side effects and the harmlessness, as well as the therapeutical benefit of the new study drug UniCAR02-T-CD123 in patients with hematologic and lymphatic malignancies positive for CD123 marker. The UniCAR02-T-CD123 drug is a combination of a cellular component (UniCAR02-T) with a recombinant antibody derivative (TM123) which together forms the active drug.

Conditions

  • Acute Myeloid Leukemia (AML)

Interventions

DRUG

Cyclophosphamide (Non-IMP)

Intravenous infusion over 3 days

DRUG

Fludarabine (Non-IMP)

Intravenous infusion over 3 days

DRUG

TM123 (IMP)

Intravenous Infusion for 20 days

DRUG

UniCAR02-T (IMP)

Intravenous infusion of single dose

Sponsors & Collaborators

  • PHARMALOG Institut für klinische Forschung GmbH

    collaborator UNKNOWN

  • AvenCell Europe GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-28
Primary Completion
2025-04-11
Completion
2025-04-11

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 NCT04230265 on ClinicalTrials.gov