MedTrace Logo

CART123 T Cells in Relapsed or Refractory CD123+ Hematologic Malignancies: A Dose Escalation Phase I Trial

NCT06765876 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-01-12

No results posted yet for this study

Summary

Adult patients with refractory or relapsed CD123+ hematologic malignancies, including acute myeloid leukemia, myelodysplastic syndrome, acute lymphoblastic leukemia, or blastic plasmocytoid dentritic cell neoplasm will be recruited in the trial. CART123 cells will be manufatured from blood of each patient. During the production of CAR123 cells, patients may receive appropriate bridging therapy. After cells are produced, participants will undergo a single course of lymphodepleting chemotherapy and receive a single dose of CAR123 T cells. The trial will establish the recommended dose for further studies, either the Maximum Tolerated Dose (MTD) or Maximum Feasible Dose (MFD). Patients must be eligible for hematopoietic stem cell transplantation in order to participate in the trial.

Conditions

  • Leukemia, Myeloid, Acute(AML)
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Myelodysplastic Syndromes (MDS)
  • Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Interventions

BIOLOGICAL

Autologous CAR123 T lymphocytes

Anti-CD123 Chimeric Antigen Receptor (CAR) T-Cells (CART123)

Sponsors & Collaborators

  • Institute of Hematology and Blood Transfusion, Czech Republic

    lead OTHER

Principal Investigators

  • Jan Vydra, MD, PhD · Institute of Hematology and Blood Transfusion, Prague, Czech Republic

  • Petr Lesný, MD, PhD · Institute of Hematology and Blood Transfusion, Prague, Czech Republic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-23
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Czechia

Study Locations

More Related Trials

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 NCT06765876 on ClinicalTrials.gov