NCT05797233View on ClinicalTrials.gov

Trial of Anti-CD19 and Anti-CD20 Bicistronic Chimeric Antigen Receptor T Cells for Treating B-Cell Malignancies

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

August 28, 2023

Primary Completion Date

December 30, 2028

Study Completion Date

December 30, 2029

Conditions
Chronic Lymphocytic LeukemiaB-Cell Chronic Lymphocytic LeukemiaLymphoma, B-Cell
Interventions
BIOLOGICAL

Anti-CD19 and anti-CD20 bicistronic CAR T- cells

0.66x10\^6 CAR+ T - 10x10\^6 CAR+ T cells/kg (weight based dosing per cohort) infused on day 0

DRUG

Cyclophosphamide

500 mg/m\^2 IV infusion over 30 minutes on days -5, -4 and -3

DRUG

Fludarabine

30 mg/m\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4,and -3

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT05797233 - Trial of Anti-CD19 and Anti-CD20 Bicistronic Chimeric Antigen Receptor T Cells for Treating B-Cell Malignancies | Biotech Hunter | Biotech Hunter