About this trial
This phase I trial tests the safety, side effects, and best dose of intracerebroventricularly (ICV) administered CD19-chimeric antigen receptor (CAR) T cells in treating patients with central nervous system (CNS) lymphoma. CAR T cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein, CD19, on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. ICV is an injection technique that delivers the CD19-CAR T cells directly into the cerebrospinal fluid (which flows in and around the hollow spaces of the brain and spinal cord, and the thin layers of tissue that cover and protect the brain and spinal cord) in the brain, through a surgically placed catheter. Giving CD19-CAR T cells ICV may be more effective at treating patients with CNS lymphoma than giving them via other methods.
Eligibility criteria
Qualifiers
Participant must have the ability to understand and the willingness to sign a written informed consent
Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated full consent is processed. However, the research participant can proceed with lymphodepletion (if applicable) and CAR T cell infusion only after the translated full consent form is signed
Agreement to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable exceptions may be granted with study principal investigator (PI) approval
Age >= 18 years
Disqualifiers
Participant has not yet recovered from toxicities of prior therapy
Presence of systemic lymphoma
Participant with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of signing the screening and leukapheresis consent
Participant with known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, including seizure disorder
Trial design
Treatments tested in this trial
- Aspiration
- Biospecimen Collection
- Catheterization
- CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem T-lymphocytes
- Computed Tomography
- Cyclophosphamide
- Fludarabine
- Leukapheresis
- Lumbar Puncture
- Magnetic Resonance Imaging
- Positron Emission Tomography
Treatment groups
Sponsors and collaborators
City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator