RecruitingPhase 1NCT06777979

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

CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With Acute Lymphoblastic Leukemia (1922CAR)


Sponsor

St. Jude Children's Research Hospital

Enrollment

30 participants

Start Date

Apr 28, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Max Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of cell therapy called CAR T cell therapy in children and young adults with acute lymphoblastic leukemia (ALL) that has come back or did not respond to previous treatments. The therapy uses the patient's own immune cells, which are genetically engineered to attack leukemia cells that carry specific proteins (CD19 and CD22). **You may be eligible if...** - You are under 21 years old - You have relapsed or refractory ALL that is positive for CD19 and/or CD22 markers - Your leukemia has come back at least twice, came back after a bone marrow transplant, or has not responded to treatment designed to cause remission - Your expected survival is more than 12 weeks - Your performance level (ability to function day-to-day) is adequate **You may NOT be eligible if...** - You have a known primary immune deficiency disorder - You have HIV - You are pregnant or breastfeeding - You have active, uncontrolled infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFludarabine

IV

DRUGCyclophosphamide

IV

DRUGMesna

IV

DEVICECD19-CD22 CAR T cell infusion

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


Locations(1)

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

View Full Details on ClinicalTrials.gov

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NCT06777979


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