NCT04608487

Axi-cel in CNS Lymphoma

A Phase I Study of Anti-CD19 CAR T-cell Therapy With Axicabtagene Ciloleucel (Axi-cel) in Patients With Relapsed/Refractory Primary and Secondary Central Nervous System (CNS) Lymphoma

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

Summary

This research is being done to test the safety and effectiveness of axicabtagene ciloleucel (axi-cel), an anti-CD19 directed chimeric antigen receptor (CAR) T-cell therapy in treating relapsed/refractory central nervous system (CNS) lymphoma, systemic lymphoma with concurrent CNS lymphoma, or systemic lymphoma with a history of treated CNS lymphoma, and to better understand what causes neurological toxicity following treatment with axi-cel. The names of the study drug(s) involved in this study are: * axicabtagene ciloleucel (axi-cel) * ludarabine will be given with axicel to help axicel work more effectively * cyclophosphamide will be given with axicel to help axicel work more effectively

Detailed description

This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied. This study will examine the safety and efficacy of axi-cel in participants who either currently or previously had had central nervous system involvement of their lymphoma. The name of the study drug involved in this study is axi-cel. Axi-cel is a chimeric antigen receptor (CAR) T-cell therapy that is manufactured using a person's own white blood cells. A virus is used to introduce a gene that creates a protein (called a CAR) on the surface of T cells, a type of blood cell that fights infection and can eliminate cancer cells. The CAR on the T cells may bind to and kill cells that express CD19, a molecule that is found on B-cell lymphomas. CAR-T cells (including axi-cel) designed to target CD19, a protein present on B lymphocytes have been used to treat patients with CD19+ tumors. This adoptive cell therapy (ACT) approach has shown significant and durable clinical benefits in the treatment of CD19+ tumors. Axi-cel has been FDA approved for the treatment of relapsed and refractory aggressive B cell lymphomas that occur outside the central nervous system and have recurred after two or more prior therapies. Participants will receive two chemotherapy medicines, fludarabine and cyclophosphamide. These drugs are not intended as direct cancer treatment but instead to help axi-cel work with less interference from immune system cells. The research study procedures include screening for eligibility and study treatment including leukapheresis, evaluations and follow up visits. Participants will receive study treatment once and will be followed for up to 15 years. It is expected that about 18 people will take part in this research study. Kite Pharma, a pharmaceutical company, is supporting this research study by providing axi-cel.

Conditions

• Lymphoma
• Lymphoma Cns

Interventions

Type	Name	Description
DRUG	Fludarabine	Intravenous infusion
DRUG	Cyclophosphamide	Intravenous infusion
BIOLOGICAL	Axicabtagene Ciloleucel	Intravenous infusion

Timeline

• Start date: 2020-12-04
• Primary completion: 2025-06-14
• Completion: 2038-06-14
• First posted: 2020-10-29
• Last updated: 2025-07-30

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study