NCT05705570

A Phase I Clinical Trial Using Genetically Engineered Autologous T Cells to Express Chimeric Antigen Receptor (CAR) for Treatment of Patients With Refractory or Relapsed CD19-positive B Lymphoid Malignancies

Study Summary

This is a phase l, single arm, prospective open, dose-escalation study in patients with relapsed or refractory CD19-positive B cell malignancies (ALL, NHL, CLL). The trial will include adult and pediatric patients. There will be three individual cohorts, defined by disease biology: pediatric ALL and aggressive pediatric NHL (Cohort 1), adult ALL (Cohort 2) and adult NHL/CLL (Cohort 3).

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Interventions

CyclophosphamideDRUG
Cyclophosphamide 60mg/Kg on day -6
FludarabineDRUG
Fludarabine 25mg/m\^2 IV on days -5 to -3
Chimeric antigen receptor T cells to be implemented in a "3 + 3" design on day 0BIOLOGICAL
Level -1 (1 x 105 cells/kg) Level 1 \[Starting dose\] (5 x 105 cells/kg) Level 2 (1 x 106 cells/kg) Level 3 (2 x 106 cells/kg)

Study Locations

FacilityCityStateCountry
Hospital Israelita Albert EinsteinSão PauloSão PauloBrazil

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026