Vaccine Responsiveness After CAR-T Cell Therapy

STATUS

Recruiting
End date

Feb 1, 2025
participants needed

41
sponsor

Fred Hutchinson Cancer Research Center

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Updated on 19 February 2024

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cancer

platelet count

cell therapy

infection prevention

biospecimen collection

inactivated rabies virus vaccine

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 (CARTx). A cohort of healthy volunteers will also be enrolled as a comparator group. CARTx is a new treatment for patients with B-cell malignancies (cancer of the B-cells), and the long-term effects of CARTx on immune function are not yet well understood. Learning more about vaccine responsiveness in patients who previously underwent CARTx may help doctors better understand immune function. The findings will guide evidence-based strategies for infection prevention to improve outcomes in this rapidly growing population of high-risk individuals.

Description

OUTLINE

Patients receive the inactivated rabies vaccine intramuscularly (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.

Details

Condition	B-Cell Neoplasm
Age	14-100 years
Treatment	Biospecimen Collection, Wistar Rabies Virus Strain PM-1503-3M Vaccine
Clinical Study Identifier	NCT04410900
Sponsor	Fred Hutchinson Cancer Research Center
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	CARTx RECIPIENTS: Patients must be capable of understanding and providing a written informed consent or, if a minor, have both parents or legal guardian be able to provide informed consent on their behalf
	CARTx RECIPIENTS: Patients must be 14 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 > 50,000 / 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 Criteria
	CARTx RECIPIENTS: Patients who have received a hematopoietic cell transplant after CARTx
	CARTx RECIPIENTS: Previously received 1 or more rabies vaccines
	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

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Vaccine Responsiveness After CAR-T Cell Therapy