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

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.

Timeline

Start

2025-07-08

Primary completion

2030-06-01

Completion

2030-12-01

Publications

• Gonzalez-Martinez B, Galan-Gomez V, Navarro-Zapata A, Mirones-Aguilar I, Cobo M, Pernas-Sanchez A, Vallejo S, Sanchez-Zapardiel E, Leon-Triana O, Echecopar C, Martinez-Romera I, Guerra-Garcia P, San Roman-Pacheco S, Escudero A, Izquierdo E, Izquierdo M, Naharro S, Martin-Ayuso A, Bareke H, Paris-Munoz A, Hu P, Schneider D, Orentas RJ, Minguillon J, Perez-Martinez A. Tandem CD19/CD22 CAR T-cells as potential therapy for children and young adults with high-risk r/r B-ALL. EBioMedicine. 2025 Aug;118:105872. doi: 10.1016/j.ebiom.2025.105872. Epub 2025 Aug 5.

Drugs

Indications