NCT03241940

Phase I Dose Escalation Study of CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies

Study Summary

This phase I trial studies the best dose and side effects of CD19/CD22 chimeric antigen receptor (CAR) T cells when given together with chemotherapy, and to see how well they work in treating children or young adults with CD19 positive B acute lymphoblastic leukemia that has come back or does not respond to treatment. A CAR is a genetically-engineered receptor made so that immune cells (T cells) can attack cancer cells by recognizing and responding to the CD19/CD22 proteins. These proteins are commonly found on B acute lymphoblastic leukemia. Drugs used in chemotherapy, such as fludarabine phosphate and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving CD19/CD22-CAR T cells and chemotherapy may work better in treating children or young adults with B acute lymphoblastic leukemia.

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Interventions

Chimeric Antigen Receptor T-Cell TherapyBIOLOGICAL
Given CD19/CD22-CAR T cells IV
CyclophosphamideDRUG
Given IV
Fludarabine PhosphateDRUG
Given IV
Laboratory Biomarker AnalysisOTHER
Correlative studies
Questionnaire AdministrationOTHER
Ancillary studies

Study Locations

FacilityCityStateCountry
Lucile Packard Children's Hospital Stanford UniversityPalo AltoCaliforniaUnited States

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026