NCT04732845

Human AntiCD19 Chimeric Antigen Receptor T Cells for Relapsed or Refractory Lymphoid Malignancies

Phase I Clinical Trial of Human AntiCD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Lymphoid Malignancies (Non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, Chronic Lymphocytic Leukemia)

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Benjamin Tomlinson · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if it is possible to treat relapsed or refractory lymphoid malignancies (Non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, Chronic Lymphocytic Leukemia) with a new type of T cell-based immunotherapy (therapy that uses the immune system to treat the cancer).

Detailed description

This study seeks to determine the safety of the treatment of relapsed or refractory B cell lymphomas, relapsed/ refractory chronic lymphocytic leukemia and relapsed/refractory acute lymphoblastic leukemia with chimeric antigen receptor T cells targeting CD19 and to find the recommended phase II dose for this cellular therapy. T cells are a type of white blood cell that helps the body fight infections. This treatment uses T cells already present within the body that have been modified outside of the body by a lentivirus and then returned to the participant by an infusion to target the cancer. Lentivirus is a family of viruses that can be used by scientists to alter cells, which then could be used to change the course of a disease. This type of treatment is sometimes referred to as adoptive cell transfer (ACT). In this study the specific type of cells that will be used is called human chimeric antigen receptor T cells (CAR-T cells). The CAR-T cells that will be reinfused to the body are modified using a lentivirus that is no longer active. The CAR-T cells will be returned to the body through an intravenous (IV) infusion. Another purpose of this study is to learn about the side effects and toxicities related to this treatment. Human CAR-T cell therapy is investigational (experimental) and works by removing T cells from the blood and modifying them to be able to target the cancer.

Conditions

• Non Hodgkin Lymphoma
• Acute Lymphoblastic Leukemia
• Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	Fully human anti CD19 CAR-T Cell Dose	Level -1 (1 x 10\^5 cells/kg) Level 1 \[Starting Dose\] (5 x 10\^5 cells/kg) Level 2 (1 x 10\^6 cells/kg) Level 3 (2 x 10\^6 cells/kg) Infusion of CAR-T cells will occur over 5-30 minutes.
DRUG	Fludarabine	25 mg/m2 daily from day -5 to -3
DRUG	Cyclophosphamide	60mg/Kg on day -6

Timeline

• Start date: 2021-04-26
• Primary completion: 2025-09-01
• Completion: 2039-12-01
• First posted: 2021-02-01
• Last updated: 2025-07-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study