A Phase I Clinical Trial of CART cell therapy for refractory/ relapsed acute lymphoblastic leukemia with unmet needs in children, adolescents and young adults: feasibility and safety study (REALL_CART).

Conditions

adolescents and young adults., Refractory/ relapsed acute lymphoblastic leukemia in children

Brief summary

In this umbrella trial, we will determine in parallel within independent cohorts: 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 T in children, adolescents and young adults with r/r T-ALL.

Detailed description

Expression of CD19/CD22 and NKG2DL on primary B- or T- cell ALL, respectively., Persistence of CART19/22 and CARTs-NKG2D cells in patients’ samples (peripheral blood, bone marrow, cerebrospinal fluid)., Peripheral blood cytokine profile from the patients’ serum., Identify the DNA methylation profile of NKG2DL (MICA, MICB AND ULBPs 1-3) in primary T-cell malignancies’ samples., Evaluate the presence of soluble NKG2DL and ANTI-MICA and ANTI-MICB antibodies in the serum of patients under CART-NKG2D therapy., Overall rate response in both arms.

González-Martínez B, Galán-Gómez V, Navarro-Zapata A, Mirones-Aguilar I, Cobo M, Pernas-Sánchez A, Vallejo S, Sánchez-Zapardiel E, León-Triana O, Echecopar C, Martínez-Romera I, Guerra-García P, San Román-Pacheco S, Escudero A, Izquierdo E, Izquierdo M, Naharro S, Martín-Ayuso A, Bareke H, París-Muñoz A, Hu P, Schneider D, Orentas RJ, Minguillón J, Pérez-Martínez A.

2025-08-05

10.1016/j.ebiom.2025.105872

Interventions

DRUGCART 19/22 T CELLS

DRUGCART45RA-NKG2D CELLS

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
In this umbrella trial, we will determine in parallel within independent cohorts: 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 T in children, adolescents and young adults with r/r T-ALL.	—

Secondary

Measure	Time frame
Expression of CD19/CD22 and NKG2DL on primary B- or T- cell ALL, respectively., Persistence of CART19/22 and CARTs-NKG2D cells in patients’ samples (peripheral blood, bone marrow, cerebrospinal fluid)., Peripheral blood cytokine profile from the patients’ serum., Identify the DNA methylation profile of NKG2DL (MICA, MICB AND ULBPs 1-3) in primary T-cell malignancies’ samples., Evaluate the presence of soluble NKG2DL and ANTI-MICA and ANTI-MICB antibodies in the serum of patients under CART-NKG2D therapy., Overall rate response in both arms.	—

Measure

Time frame

Expression of CD19/CD22 and NKG2DL on primary B- or T- cell ALL, respectively., Persistence of CART19/22 and CARTs-NKG2D cells in patients’ samples (peripheral blood, bone marrow, cerebrospinal fluid)., Peripheral blood cytokine profile from the patients’ serum., Identify the DNA methylation profile of NKG2DL (MICA, MICB AND ULBPs 1-3) in primary T-cell malignancies’ samples., Evaluate the presence of soluble NKG2DL and ANTI-MICA and ANTI-MICB antibodies in the serum of patients under CART-NKG2D therapy., Overall rate response in both arms.

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Countries

Spain

Outcome results

None listed