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CAR T-cell Therapy
CAR T-Cells + CMV-MVA Triplex Vaccine for Non-Hodgkin's Lymphoma
Phase 1
Recruiting
Led By Leslie L Popplewell
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 time from the start of lymphodepletion to the time of disease relapse, progression or death, whichever occurs first, assessed at 1 year and up to 15 years
Awards & highlights
Study Summary
This trial tests CAR T cells & CMV-MVA triplex vaccine to treat relapsed/refractory NHL. CAR T cells are changed to attack cancer cells & vaccine helps body build immune response to kill cancer.
Who is the study for?
Adults with relapsed or refractory B-cell non-Hodgkin lymphoma, who are CMV seropositive and have a life expectancy of at least 16 weeks. They must be in good physical condition (KPS >= 70), not pregnant, willing to use birth control, and without significant heart, liver or kidney issues. Excluded are those with active autoimmune disease on treatment, recent allogeneic stem cell transplant recipients, or anyone on investigational agents.Check my eligibility
What is being tested?
The trial is testing genetically modified T-cells targeting CD19 on cancer cells plus a CMV-based vaccine after chemotherapy that reduces immune cells (lymphodepletion). It aims to see if this combination can help the body's immune system fight the lymphoma more effectively.See study design
What are the potential side effects?
Potential side effects include reactions related to the infusion of T-cells such as fever and chills; organ inflammation due to an overactive immune response; blood count changes; fatigue; risk of infection from weakened immunity post-chemotherapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from the start of lymphodepletion to the time of disease relapse, progression or death, whichever occurs first, assessed at 1 year and up to 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from the start of lymphodepletion to the time of disease relapse, progression or death, whichever occurs first, assessed at 1 year and 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
Incidence of adverse events
Incidence of dose-limiting toxicity
Secondary outcome measures
Clinically significant CMV reactivation
Disease response (complete response/minor response/partial response/disease progression/stable disease)
Feasibility as assessed by the ability to meet the required cell dose and product release requirement
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (CMV-specific CD19-CAR T cells, triplex vaccine)Experimental Treatment10 Interventions
Patients undergo leukapheresis on day -30 and receive lymphodepleting chemotherapy on days -10 to -3 per SOC on study. Patients then receive CMV-specific CD19-CAR T cells IV on day 0 and CMV-MVA triplex vaccine IM on days 28 and 56 in the absence of unacceptable toxicity on study. Patients also undergo x-ray during screening and on study, as well as PET, CT, MRI, blood sample collection, and bone marrow biopsy on study and during follow-up.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
2008
Completed Phase 2
~2210
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Leukapheresis
2016
Completed Phase 2
~690
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Biospecimen Collection
2004
Completed Phase 2
~1720
Computed Tomography
2017
Completed Phase 2
~2720
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
570 Previous Clinical Trials
1,922,601 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,703 Previous Clinical Trials
40,931,735 Total Patients Enrolled
Leslie L PopplewellPrincipal InvestigatorCity of Hope Medical Center
2 Previous Clinical Trials
23 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently using steroids or immunosuppressant medications regularly.I don't have any health issues that would prevent me from receiving chemotherapy or CAR T-cell therapy.My cancer is confirmed to be a certain type of aggressive CD19+ cancer.I had a stem cell transplant from a donor and have recovered without active GVHD.I have not had a platelet transfusion in the last week.I have no allergies or adverse reactions to specific medical treatments or vaccines.I am currently taking antibiotics for an infection.I have had optic neuritis or other immune-related diseases affecting my brain or spinal cord.I have active viral hepatitis.I am 18 years old or older.I have not used growth factors in the last 14 days.I am on medication for an autoimmune disease.My kidney function is within the required range and I am not on dialysis.I am capable of having children and have not been surgically sterilized.I have not had a stroke or brain bleed in the last 6 months.I may not have tissue samples available, but can get approval from the study leader.I am not currently on any experimental treatments or other cancer therapies.I am able to care for myself but may not be able to do active work.I have B cell NHL and cannot or do not wish to undergo a stem cell transplant.I have a bleeding disorder like von Willebrand's or hemophilia.I do not have any uncontrolled serious illnesses.My heart pumps well, with an ejection fraction of 45% or higher.I had cancer before, but it was either removed surgically with the aim of curing it, or it was a type of skin cancer or non-muscle invasive bladder cancer that's been inactive for 3+ years.My heart rhythm problem is not controlled by medication.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (CMV-specific CD19-CAR T cells, triplex vaccine)
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.
Is Treatment (CMV-specific CD19-CAR T cells, triplex vaccine) considered a safe medicinal procedure?
"Our team at Power has assessed the safety of CMV-specific CD19-CAR T cells and triplex vaccine to be a 1. This is due to this being an early Phase 1 trial, thus there are only limited data that demonstrate its efficacy or safety."
Answered by AI
Is this experiment still enrolling participants?
"Per the clinicaltrials.gov database, this trial is not presently enrolling participants. Initially posted on September 13th 2023 and updated lastly on April 5th 2023, there are no current openings for patients yet 1749 other trials have vacancies at present."
Answered by AI
What objectives are the researchers hoping to accomplish with this experiment?
"During this 28-day clinical trial, the primary outcome to be evaluated is adverse event incidence. Secondary outcomes include short and long-term CMV-specific CD19 chimeric antigen receptor T cell expansion and persistence (measured by detection of 0.1% or more CMV cells in peripheral blood), clinically significant CMV reactivation requiring treatment management after CAR T infusion (defined as over 1250 IU/ml or 500 GC per mL) ,and disease response evaluation according to International Working Group consensus criteria 2017. The trend of CAR T cells over time will be assessed using linear mixed effects modeling with a graphical overlay scatter plot generated from the"
Answered by AI
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