Treatment (leukapheresis, CD19-CAR T cells) for Central Nervous System Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Central Nervous System LymphomaMagnetic Resonance Imaging - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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 primary 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 primary CNS lymphoma than giving them via other methods.

Eligible Conditions
  • Central Nervous System Lymphoma

Treatment Effectiveness

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: Up to 15 years

At 6 months
PFS time
Year 1
B cell level
Chimeric antigen receptor (CAR) T and endogenous T cell levels and phenotype
Up to 15 years
Anemia, neutropenia, thrombocytopenia, and hypogammaglobulinemia lasting longer than 60 days or deemed medically significant
Cytokine levels
Disease response
Incidence of adverse events
Overall survival (OS) time

Trial Safety

Trial Design

1 Treatment Group

Treatment (leukapheresis, CD19-CAR T cells)
1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Treatment (leukapheresis, CD19-CAR T cells) · No Placebo Group · Phase 1

Treatment (leukapheresis, CD19-CAR T cells)Experimental Group · 11 Interventions: Magnetic Resonance Imaging, Aspiration, Fludarabine, Cyclophosphamide, Catheterization, Positron Emission Tomography, Biospecimen Collection, Leukapheresis, Lumbar Puncture, CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T-lymphocytes, Computed Tomography · Intervention Types: Procedure, Procedure, Drug, Drug, Procedure, Procedure, Procedure, Procedure, Procedure, Biological, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 2
~1100
Aspiration
2013
N/A
~140
Fludarabine
2012
Completed Phase 3
~1170
Cyclophosphamide
1995
Completed Phase 3
~3930
Catheterization
2015
N/A
~430
Positron Emission Tomography
2008
Completed Phase 2
~2820
Biospecimen Collection
2004
Completed Phase 1
~670
Leukapheresis
2010
Completed Phase 2
~510
Lumbar Puncture
2006
Completed Phase 2
~210
Computed Tomography
2017
Completed Phase 2
~3410

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 15 years

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
515 Previous Clinical Trials
2,248,060 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,070 Previous Clinical Trials
41,129,037 Total Patients Enrolled
8 Trials studying Central Nervous System Lymphoma
457 Patients Enrolled for Central Nervous System Lymphoma
Tanya SiddiqiPrincipal InvestigatorCity of Hope Medical Center
3 Previous Clinical Trials
91 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have the ability to understand and the willingness to sign a written informed consent.
If available, the study may use archival tissue from diagnostic tumor biopsies.
You have a performance status of 0 - 2.
You have a documented current CD19+ tumor expression if prior CD19 directed therapy was used.
You have no known contraindications to leukapheresis, steroids or tocilizumab.
You are of reproductive potential and agree to use acceptable birth control methods throughout study therapy and for 3 months after final dose of study treatment.