NCT04892277

Phase I Dose Escalation Trial of CD19 Directed Chimeric Antigen Receptor T Cell Therapy in the Treatment of Relapsed/Refractory B Cell Malignancies

Study Summary

This phase I trial studies the effects of CD-19 directed chimeric antigen receptor (CAR)-T cell therapy for the treatment of patients with B cell malignancies that have come back (recurrent) or have not responded to treatment (refractory). CD-19 CAR-T cells use some of a patient's own immune cells, called T cells, to kill cancer. T cells fight infections and, in some cases, can also kill cancer cells. Some T cells are removed from the blood, and then laboratory, researchers will put a new gene into the T cells. This gene allows the T cells to recognize and possibly treat cancer. The new modified T cells are called the IC19/1563 treatment. IC19/1563 may help treat patients with relapsed/refractory B cell malignancies.

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Interventions

Autologous Anti-CD19 CAR-expressing T-lymphocytes IC19/1563BIOLOGICAL
Given IV
BendamustineDRUG
Given IV
Biospecimen CollectionPROCEDURE
Undergo collection of blood and tissue samples
Bone Marrow AspirationPROCEDURE
Undergo bone marrow aspiration
Bone Marrow BiopsyPROCEDURE
Undergo bone marrow biopsy
Computed TomographyPROCEDURE
Undergo CT
CyclophosphamideDRUG
Given IV
FludarabineDRUG
Given IV
Magnetic Resonance ImagingPROCEDURE
Undergo MRI
Positron Emission TomographyPROCEDURE
Undergo CT/PET

Study Locations

FacilityCityStateCountry
Mayo Clinic in RochesterRochesterMinnesotaUnited States

Official Trial Information

View on ClinicalTrials.gov

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