NCT06101381

CD19-directed CAR-T Cell Therapy for Refractory or Relapsed Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma: a Multicenter Phase I/II Trial.

Study Summary

The goal of this prospective, multicentric, single-arm, phase I/II clinical trial is to evaluate the safety and efficacy of a novel CD19-directed CAR-T cell locally produced in an academic institution in Brazil in patients with refractory or relapsed acute lymphoblastic leukemia or non-Hodgkin lymphoma. Participants will receive a single intravenous infusion of an autologous academic anti-CD19 CAR-T cell and will be followed for 5 years.

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Interventions

CART-19BIOLOGICAL
The academic CART-19 consists of autologous T lymphocytes transduced with a lentiviral vector to express a second-generation chimeric antigen receptor with a single chain variable fragment (scFv) targeting the CD19 antigen conjugated with 4-1BB co-stimulatory and CD3z signaling domains.

Study Locations

FacilityCityStateCountry
Hospital de Clínicas da UNICAMPCampinasSão PauloBrazil
Ribeirao Preto School of Medicine, University of Sao PauloRibeirão PretoSão PauloBrazil
Hospital Sírio-LibanêsSão PauloSão PauloBrazil
Hospital das Clinicas de São PauloSão PauloSão PauloBrazil
A Beneficência Portuguesa de São PauloSão PauloSão PauloBrazil

Official Trial Information

View on ClinicalTrials.gov

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