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Vaccine Response After CAR-T Therapy for B-Cell Lymphoma
Phase 1
Recruiting
Led By Joshua A. Hill
Research Sponsored by Fred Hutchinson Cancer Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
HEALTHY CONTROLS: Patients must be 18 years of age or older, of any gender, race or ethnicity
CARTx RECIPIENTS: Patients must have had relapse-free survival for >= 6 months after receiving CARTx for B-cell malignancies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks after the secondary vaccination
Awards & highlights
Study Summary
This trial will use an inactivated rabies virus vaccine to test immune function in patients who have undergone a new cancer treatment called CARTx. A group of healthy volunteers will also be enrolled to provide a comparison. CARTx is a new treatment for patients with cancer of the B-cells, and the long-term effects of CARTx on immune function are not yet well understood. This trial may help doctors better understand immune function and improve outcomes for this growing population of high-risk individuals.
Who is the study for?
This trial is for adults who've had B-cell targeted CAR-T cell therapy and been relapse-free for at least 6 months. It's also open to healthy adults as a comparison group. Participants must understand the study and consent in writing. Exclusions include pregnancy, breastfeeding, prior rabies vaccines, severe vaccine reactions, certain medication use, active infections, known allergies to vaccine components or medical attention-requiring reactions to any vaccine.Check my eligibility
What is being tested?
The trial tests immune function using an inactivated rabies virus vaccine in patients previously treated with CAR-T cell therapy compared to healthy volunteers. The goal is to learn how well these patients respond to vaccines after their cancer treatment and guide strategies for infection prevention.See study design
What are the potential side effects?
Potential side effects from the rabies vaccine may include soreness at injection site, headache, nausea, muscle aches or dizziness. Severe allergic reactions are rare but can occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older and willing to participate as a healthy control.
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I have been free from cancer for at least 6 months after receiving CARTx therapy for B-cell cancer.
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I am 18 years or older and interested in CARTx therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks after the secondary vaccination
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks after the secondary vaccination
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants with positive vaccine response
Secondary outcome measures
Longitudinal rabies virus binding IgG antibody titers
Longitudinal rabies virus binding IgM antibody titers
Longitudinal rabies virus neutralizing antibody (RVNA) titers
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental (anti-rabies vaccine, collection of blood)Experimental Treatment2 Interventions
BOLUS COHORT: Patients receive the inactivated rabies vaccine IM on day 1 and 6-10 weeks later. Patients also undergo a blood collection prior to each vaccine, and at approximately 1, 2, and 4 weeks after each vaccination. A final blood collection occurs 6 months after the first immunization.
FRACTIONAL DOSE COHORT: Patients receive the inactivated rabies vaccine fractionated primary dose IM on days 1, 3, 7, 10, 14, and 17 and the second dose 6-10 weeks later. Patients also undergo a blood collection prior to each vaccine, and at approximately 1, 2, and 4 weeks after each vaccination. A final blood collection occurs 6 months after the first immunization.
Group II: Control (anti-rabies vaccine, collection of blood)Active Control2 Interventions
Patients receive anti-rabies vaccine IM on day 1 and 6-10 weeks later. Patients also undergo collection of blood samples at baseline, and at approximately 1, 2, and 4 weeks after each vaccination. There will be an additional blood draw 6 months (+/- 14 days) after the first immunization.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1730
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,202 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
556 Previous Clinical Trials
1,343,225 Total Patients Enrolled
Joshua A. HillPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a severe reaction to the first rabies vaccine and cannot take a second dose.I am 18 or older and willing to participate as a healthy control.I have been free from cancer for at least 6 months after receiving CARTx therapy for B-cell cancer.I am showing signs of an active infection.You do not have any chronic illnesses.I have been taking more than a low dose of steroids before my vaccine.I have received at least one rabies vaccine before my first vaccine visit.I have had a stem cell transplant after receiving CAR T-cell therapy.I received a treatment to lower my white blood cells after CARTx therapy within the last 6 months.If you have had an allergic reaction to any part of the vaccine before, you cannot participate.I am currently pregnant or breastfeeding.I am healthy and do not have signs of an active infection.I have received at least one rabies vaccine.I am 18 years or older and interested in CARTx therapy.You had a serious medical reaction to a vaccine in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Control (anti-rabies vaccine, collection of blood)
- Group 2: Experimental (anti-rabies vaccine, collection of blood)
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.
Does this clinical trial represent an unprecedented approach?
"Biospecimen Collection has been under scientific evaluation since 2019, initiated by Sanofi Pasteur. Initial trials involving 1700 participants enabled the drug to reach Phase 3 approval with two currently active studies across two nations and a single city."
Answered by AI
Is the process of collecting biospecimens authorized by the FDA?
"Taking into account the limited data available on its safety and efficacy, Biospecimen Collection is rated as a 1 on our team's scale."
Answered by AI
Is it currently feasible to participate in this trial?
"Absolutely. According to records on clinicaltrials.gov, this medical experiment is currently accepting applicants, with the initial post occurring on August 3rd 2020 and an update posted as recently as October 19th 2022. 41 patients are required at a single site for participation in the trial."
Answered by AI
How many individuals are partaking in this clinical research?
"Affirmative. According to information on clinicaltrials.gov, this research study is actively seeking participants after being posted on August 3rd 2020 and recently updated on October 19th 2022. A total of 41 patients need to be enrolled at one site for the trial to proceed."
Answered by AI
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