RecruitingEarly Phase 1NCT06765876

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

Safety and Efficacy of Anti-CD123 Chimeric Antigen Receptor-Modified Autologous T Cells (CART123) in Patients With Relapsed/Refractory CD123+ Hematologic Malignancies: A Dose Escalation, Open-Label, Phase I Study


Sponsor

Institute of Hematology and Blood Transfusion, Czech Republic

Enrollment

18 participants

Start Date

Oct 23, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new CAR-T cell therapy (CART123) — a type of personalized immune cell treatment — for patients with blood cancers that have come back or stopped responding to other treatments. CAR-T therapy involves modifying your own immune cells to recognize and attack cancer cells. **You may be eligible if...** - You have been diagnosed with AML (acute myeloid leukemia), MDS, BPDCN, or ALL, and your cancer tests positive for a protein called CD123 - Your cancer has relapsed or is refractory (failed to respond) after at least 2 prior treatments, including standard induction chemotherapy or CAR-T targeting CD19 - You have had a relapse after a stem cell transplant - For ALL patients: your cancer stopped responding to CAR-19 therapy or you are not eligible for other standard options **You may NOT be eligible if...** - Your blood cancer does not express the CD123 protein - You have active uncontrolled infections - Your organ function is too poor to handle this type of therapy - You have certain active autoimmune conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALAutologous CAR123 T lymphocytes

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


Locations(1)

Ustav hematologie a krevni transfuze / Institute of Hematology and Blood Transfusion

Prague, Czechia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06765876


Related Trials