Ignite Creation Date:
2024-05-06 @ 2:46 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04410900
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2020-05-28
Brief Title:
Vaccine Responsiveness After CAR-T Cell Therapy
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Rabies Vaccination to Assess Vaccine Responsiveness After B Cell Targeted CAR-T Cell Therapies
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 malignancies and healthy individuals The target enrollment for this trial is 43 CARTx recipients and 10 healthy controls The study is open to anyone regardless of gender or ethnicity
OUTLINE
BOLUS COHORT 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 This will include up to 31 participants
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 This will include up to 12 participants
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 malignancies and healthy individuals The target enrollment for this trial is 43 CARTx recipients and 10 healthy controls The study is open to anyone regardless of gender or ethnicity
OUTLINE
BOLUS COHORT 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 This will include up to 31 participants
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 This will include up to 12 participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10411 | OTHER | Fred HutchUniversity of Washington Cancer Consortium | None |
| NCI-2020-03444 | REGISTRY | None | None |