Study of CD19-directed Allogeneic Memory T-cell Therapy for Relapsed/Refractory CD19+ Leukemia
Status:
Recruiting
Trial end date:
2026-01-01
Target enrollment:
Participant gender:
Summary
This is a Phase I clinical study evaluating the safety and maximum tolerated dose of a novel
CAR T-cell product: allogeneic memory (CD45RA- negative) T-cells expressing a CD19-specific
CAR 41BBz (CD19-CAR.CD45RA- negative T-cells) for the treatment of patients ≤ 21 years old
with relapsed and/ or refractory CD19-positive leukemia.
Primary Objective
To determine the maximum tolerated dose (MTD) and characterize the safety profile and
dose-limiting toxicities (DLTs) of treatment with allogeneic CD19-CAR.CD45RA-negative T-cells
in pediatric, adolescent and young adult patients ≤ 21 years of age, with relapsed and/or
refractory CD19-positive leukemia.
Secondary Objectives
- To evaluate the anti-leukemic activity of allogeneic CD19-CAR.CD45RA-negative T-cells.
- To determine rates and severity of graft-versus-host-disease (GVHD) after treatment with
allogeneic CD19-CAR.CD45RA-negative T-cells.
Exploratory Objectives
- To study the expansion, persistence and phenotype of allogeneic CD19-CAR.CD45RA-negative
T-cells.
- To characterize the cytokine profile in the peripheral blood and CSF after treatment
with allogeneic CD19-CAR.CD45RA-negative T-cells.
- To assess whether allogeneic CD19-CAR.CD45RA-negative T-cells acquire functional versus
exhaustion-associated epigenetic programs.
- To determine the clonal structure and endogenous repertoire of allogeneic
CD19-CAR.CD45RA-negative T-cells and relate inferred specificity to CAR response
profiles.
- To characterize incidence and mechanisms of relapse post-therapy with allogeneic
CD19-CAR.CD45RA-negative T-cells.