NCT06364423View on ClinicalTrials.gov

Anti-CD19 Chimeric Antigen Receptor T-Cell Immunotherapy for Chronic Lymphocytic Leukemia (CLL)

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

132

Participants

Timeline

Start Date

September 3, 2024

Primary Completion Date

July 1, 2029

Study Completion Date

July 1, 2030

Conditions
B-Cell Chronic Lymphocytic LeukemiaLeukemia, Lymphocytic, Chronic, B-CellB-Lymphocytic Leukemia, Chronic
Interventions
BIOLOGICAL

Autologous HuCD19 ( Anti-CD19)CAR T cells

1.0x10\^6 CAR+T-cells - 12x10\^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

DRUG

Rituximab

500 mg/m2 IV infusion over 30 minutes on day -5; 375 mg/m2 IV infusion over 30 minutes on days 2-9 prior to apheresis

Trial Locations (1)

20892

RECRUITING

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH