Your session is about to expire
← Back to Search
CAR T-cell Therapy
CAR T-Cell Therapy for Brain Lymphoma
Phase 1
Recruiting
Led By Tanya Siddiqi
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years
Awards & highlights
Study Summary
This trial tests the safety & effects of CAR T cells to treat brain lymphoma delivered directly into the brain.
Who is the study for?
Adults (18+) with primary CNS lymphoma, measurable disease, and CD19+ tumor expression can join this trial. They must have tried certain treatments like high-dose methotrexate or cytarabine without success. Participants need to be in fair health (ECOG 0-2), able to consent, and agree to use birth control. Exclusions include uncontrolled infections, active autoimmune diseases needing strong meds, HIV, hepatitis B/C infection, other cancers within the last 3 years (except some skin cancers), history of stroke or bleeding disorders.Check my eligibility
What is being tested?
This phase I trial is testing a new way to deliver CAR T-cell therapy for CNS lymphoma by injecting modified immune cells directly into the brain's fluid via a catheter. It aims to find out the safest dose and observe side effects when these engineered T-cells target cancer cells expressing CD19 protein.See study design
What are the potential side effects?
Potential side effects may include reactions at the infusion site, changes in blood counts leading to increased infection risk or bleeding tendencies, fatigue, fever due to immune response activation called cytokine release syndrome (CRS), neurological events such as confusion or seizures related to treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease response
Incidence of adverse events
Secondary outcome measures
Anemia, neutropenia, thrombocytopenia, and hypogammaglobulinemia lasting longer than 60 days or deemed medically significant
B cell level
Chimeric antigen receptor (CAR) T and endogenous T cell levels and phenotype
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (leukapheresis, CD19-CAR T cells)Experimental Treatment11 Interventions
Patients may undergo catheterization, undergo leukapheresis, may receive fludarabine IV and cyclophosphamide IV, and receive CD19-CAR T cells ICV on study. Patients also undergo MRI, PET, CT, collection of blood samples, and CSF aspiration throughout the trial, and lumbar puncture as clinically indicated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aspiration
2013
N/A
~140
Catheterization
2015
Completed Early Phase 1
~440
Positron Emission Tomography
2008
Completed Phase 2
~2240
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Leukapheresis
2016
Completed Phase 2
~690
Biospecimen Collection
2004
Completed Phase 2
~1700
Cyclophosphamide
1995
Completed Phase 3
~3770
Fludarabine
2012
Completed Phase 3
~1100
Lumbar Puncture
2016
Completed Phase 3
~510
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,834 Total Patients Enrolled
7 Trials studying Central Nervous System Lymphoma
408 Patients Enrolled for Central Nervous System Lymphoma
City of Hope Medical CenterLead Sponsor
567 Previous Clinical Trials
1,922,640 Total Patients Enrolled
Tanya SiddiqiPrincipal InvestigatorCity of Hope Medical Center
3 Previous Clinical Trials
91 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My recent heart test shows no serious issues needing further checks or treatment.I am still experiencing side effects from my previous cancer treatment.I haven't had a stroke or brain bleed in the last 6 months.I have been cancer-free for over 3 years, except for minor skin cancers.I am HIV positive.My heart rhythm problem is not stable even with medication.My kidneys are functioning well, with a creatinine clearance of at least 50 mL/min.I do not have any serious infections.I am 18 years old or older.I have received CAR T cell therapy before.I am a woman who can have children and have a recent negative pregnancy test.I am on medication for an autoimmune disease.My oxygen levels are above 92% without needing extra oxygen.I have a bleeding disorder like von Willebrand's disease or hemophilia.I have no allergies or adverse reactions to leukapheresis, steroids, or tocilizumab.I need more than 4mg/day of dexamethasone before my cell therapy.My cancer still shows CD19 positivity after previous CD19-targeted treatment.I must monitor my hepatitis B with regular tests if I join the study.I am able to get out of my bed or chair and move around.I have a history of optic neuritis or other immune-related CNS conditions, including seizures.I do not have an active hepatitis B or C infection.I currently have an infection that isn't responding to treatment.I've tried and didn't respond well to specific brain cancer treatments.I have a confirmed primary CNS lymphoma with measurable disease.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (leukapheresis, CD19-CAR T cells)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned leukapheresis, CD19-CAR T cells for therapeutic applications?
"Treatment (leukapheresis, CD19-CAR T cells) received a score of 1 due to the small amount of evidence existing for its safety and efficacy in this Phase 1 trial."
Answered by AI
Is it still possible to submit an application for this research study?
"Clinicaltrials.gov documents this clinical trial as non-recruiting, with the initial posting date of December 30th 2022 and last update on November 15th 2022. Despite that, there are still 1,718 other trials presently seeking enrolment from candidates."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger