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

NCT06777979 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Fludarabine

IV

DRUG

Cyclophosphamide

IV

DRUG

Mesna

IV

DEVICE

CD19-CD22 CAR T cell infusion

CAR T cell infusion will be given intravenously, either centrally or peripherally.

Sponsors & Collaborators

Principal Investigators

  • Rebecca Epperly, MD · St. Jude Children's Research Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-28
Primary Completion
2030-01-31
Completion
2031-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06777979 on ClinicalTrials.gov