Who is sponsoring NCT03298828?

NCT03298828 is sponsored by Third Military Medical University.

What condition does NCT03298828 study?

NCT03298828 studies Acute Lymphoblastic Leukemia, Burkitt Lymphoma.

What drugs are being tested in NCT03298828?

Interventions: CD19 CAR and PD-1 knock out engineered T-cells, CD19 CAR T-cells.

What is the status of NCT03298828?

NCT03298828 is currently UNKNOWN.

Last reviewed 2017-09-26 · How we verify

CD19 Chimeric Antigen Receptor (CAR) and PD-1 Knockout Engineered T Cells for CD19 Positive Malignant B-cell Derived Leukemia and Lymphoma

NCT03298828 Phase 1 UNKNOWN

The purpose of this study is to evaluate the safety, efficacy and blood kinetics of autologous T cells genetically modified to express CD19 Chimeric Antigen Receptor and PD-1 knockout engineered T cells in patients with relapsed or refractory B-Cell Non-Hodgkin Lymphoma and Leukaemia.

Details

Lead sponsor	Third Military Medical University
Phase	Phase 1
Status	UNKNOWN
Enrolment	30
Start date	2017-11
Completion	2022-10

Conditions

Acute Lymphoblastic Leukemia
Burkitt Lymphoma

Interventions

CD19 CAR and PD-1 knock out engineered T-cells
CD19 CAR T-cells

Primary outcomes

Molecular remission — 1 month
Efficacy will be assessed by determining Minimal Residual Disease in the bone marrow aspirate using immunoglobulin heavy chain (IgH) quantitative polymerase chain reaction (qPCR) and/or Next Generation Sequencing in all patients. The proportion of patients achieving molecular remission at 1 month post CD19 CAR and PD-1 Knockout Engineered T-cell infusion will be determined.