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

PHASE1RecruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

July 8, 2025

Primary Completion Date

June 1, 2030

Study Completion Date

December 1, 2030

Conditions
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Interventions
BIOLOGICAL

Autologous CD19/CD22 CAR T cells

A total of two doses of autologous CD19/CD22 CAR T cells (first dose of up to 0.75x106/kg fresh cells), and a second infusion of unfrozen cells (same dose) if there has been no ≥ grade 1 cytokine-release syndrome (CRS) in the next 72 h; intravenously.

BIOLOGICAL

Allogeneic CART-NKG2D cells

A total of up to 3x106/kg allogeneic CART-NKG2D cells divided in three doses of up to 1x106/kg will be infused; intravenously. First infusion of fresh cells, and the 2nd and 3rd infusion of unfrozen cells (same dose) if there has been no ≥ grade 1 CRS (every 48 hours).

Trial Locations (1)

28046

RECRUITING

Hospital Universitario La Paz, Madrid

All Listed Sponsors
lead

Instituto de Investigación Hospital Universitario La Paz

OTHER

NCT06709469 - Phase I Clinical Trial of CART Cell Therapy for Refractory/Relapsed Acute Lymphoblastic Leukemia in Children, Adolescents and Young Adults | Biotech Hunter | Biotech Hunter