Clinical Trial

Phase I Clinical Trial of CART Cell Therapy for Refractory/Relapsed Acute Lymphoblastic Leukemia in Children, Adolescents and Young Adults

Study acronym: REALL_CART
Recruiting Phase 1
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Summary
The goal of this clinical trial is to test the feasibility and safety of an academic production of two different anti-CD19 chimeric antigen receptor T cells (CART) products according to the different biomarkers of the disease in children and young adults with relapsed/refractory CD19+ B cell acute lymphoblastic leukemia (r/r B-ALL) or relapsed/refractory T-cell acute lymphoblastic leukemia (r/r T-ALL). The main questions it aims to answer are: 1. The safety and feasibility of autologous CART-19/22 in children, adolescents and young adults with a CD19+/- CD22+ relapse/ refractory disease for a r/r B-ALL. 2. The safety and feasibility of allogeneic CART-NKG2D (chimeric-antigen receptor Natural-killer group 2, member D) in children, adolescents and young adults with r/r T-ALL.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-11-25.
Status change: Not Yet Recruiting → Recruiting 2025-09-19
Trial Details
NCT Number NCT06709469
Lead Sponsor Instituto de Investigación Hospital Universitario La Paz
Conditions Precursor Cell Lymphoblastic Leukemia-Lymphoma
Enrollment 10 participants
Start Date 2025-07-08
Primary Completion 2030-06-01 (estimated)
Study Completion 2030-12-01 (estimated)
Updated on ClinicalTrials.gov 2025-09-22