CART123 T Cells in Relapsed or Refractory CD123+ Hematologic Malignancies: A Dose Escalation Phas… (NCT06765876) | Clinical Trial Compass
RecruitingEarly Phase 1
CART123 T Cells in Relapsed or Refractory CD123+ Hematologic Malignancies: A Dose Escalation Phase I Trial
Czechia18 participantsStarted 2024-10-23
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Patients with AML, MDS-IB2, BPDCN or ALL positive for CD123 antigen, who meet one of disease specific criteria below:
✓. CD123 expression on malignant cells confirmed by flow cytometry or by immunohistochemistry.
✓. Age between 18 and 70 years.
✓. Patient has a suitable donor for allogeneic hematopoietic stem cell transplantation. Workup and clearance of the donor must be completed before IMP administration.
✓. Patient able to understand and sign informed consent.
✓. Women of child-bearing potential: negative pregnancy test at enrolment (PSV) and at Visit 1.
✓. Patient for whom there are no standard-of-care treatments available or such treatment options have been exhausted.
Exclusion criteria
✕. Known hypersensitivity to any component of the IMP.
✕. Allogeneic HSCT within 3 months prior to IMP administration.
What they're measuring
1
Safety and tolerability of autologous CART123 cells