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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

Be older than 18 years old

Must not have

CARTx RECIPIENTS: Study participants who report a severe adverse event following the first rabies vaccine will not be eligible for a second dose

CARTx RECIPIENTS: Patients with signs or symptoms of active infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks after the secondary vaccination

Awards & highlights

No Placebo-Only Group

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.

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.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had a severe reaction to the first rabies vaccine and cannot take a second dose.

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I am showing signs of an active infection.

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I have been taking more than a low dose of steroids before my vaccine.

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I have received at least one rabies vaccine before my first vaccine visit.

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I have had a stem cell transplant after receiving CAR T-cell therapy.

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I am currently pregnant or breastfeeding.

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I am healthy and do not have signs of an active infection.

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I have received at least one rabies vaccine.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks after the secondary vaccination for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of participants with positive vaccine response

Secondary study objectives

Longitudinal rabies virus binding IgG antibody titers

Longitudinal rabies virus binding IgM antibody titers

Longitudinal rabies virus neutralizing antibody (RVNA) titers

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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 3

~2030

0 / 8Eligibility criteria met