drugset / Trial / NCT06777979

CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With Acute Lymphoblastic Leukemia

NCT06777979

Phase 1 Recruiting 30 enrolled St. Jude Children's Research Hospital
NaSingle-groupOpen-labelTreatment

Summary

This study is a phase I study designed to evaluate the safety of CD19-CD22-CAR T cells. Primary Objective: To determine the safety profile and propose the recommended phase 2 dose (RP2D) of autologous CD19-CD22-CAR T cells in patients ≤ 21 years of age with recurrent/refractory CD19- and/or CD22-positive leukemia. Secondary Objective: To evaluate the anti-leukemic activity of CD19-CD22-CAR T cells.

Timeline

Start
2025-04-28
Primary completion
2030-01
Completion
2031-01

Drugs

EvaluationDrugModalityDoseRoute
Background 2-MERCAPTOETHANESULFONIC ACID Small molecule
Background Cyclophosphamide Other / unclassified
Background Fludarabine Small molecule