Status:
COMPLETED
Vaccine Responsiveness After CAR-T Cell Therapy
Lead Sponsor:
Fred Hutchinson Cancer Center
Conditions:
B-Cell Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial will use the inactivated rabies virus vaccine to assess immune function in patients who previously underwent B cell targeted chimeric antigen receptor-modified T cell immunotherapy ...
Detailed Description
STUDY DESIGN: This study will be a prospective, open-label clinical trial of primary and secondary vaccination with the inactivated rabies vaccine in patients treated with CARTx for B cell malignanci...
Eligibility Criteria
Inclusion
- CARTx RECIPIENTS: Patients must be capable of understanding and providing a written informed consent
- CARTx RECIPIENTS: 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
- CARTx RECIPIENTS: Platelet count \> 30,000 / mm\^3
- HEALTHY CONTROLS: Patients must be capable of understanding and providing a written informed consent
- HEALTHY CONTROLS: Patients must be 18 years of age or older, of any gender, race or ethnicity
Exclusion
- CARTx RECIPIENTS: Patients who have received a hematopoietic cell transplant after CARTx
- CARTx RECIPIENTS: Previously received 1 or more rabies vaccines prior to the first vaccine visit
- CARTx RECIPIENTS: Patients who have received lymphodepleting therapies after CARTx and within the past 6 months
- CARTx RECIPIENTS: Patients with signs or symptoms of active infection
- CARTx RECIPIENTS: Patients who are pregnant or breastfeeding
- CARTx RECIPIENTS: Patients with previous known allergies to any component of the vaccine
- CARTx RECIPIENTS: Patients who have previously experienced a reaction to any vaccine that required medical attention
- 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: Receiving corticosteroids \> 0.5 mg/kg/day prednisone equivalence in the 7 days prior to first or second vaccination
- HEALTHY CONTROLS: Previously received 1 or more rabies vaccines
- HEALTHY CONTROLS: Chronic illness
- HEALTHY CONTROLS: Signs or symptoms of active infection
- HEALTHY CONTROLS: Pregnant or breastfeeding
- HEALTHY CONTROLS: Patients with previous known allergies to any component of the vaccine
- HEALTHY CONTROLS: Previous reaction to a vaccine that required medical attention
Key Trial Info
Start Date :
August 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2025
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT04410900
Start Date
August 3 2020
End Date
August 31 2025
Last Update
September 8 2025
Active Locations (1)
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1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109