Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06334991
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-03-05
Brief Title:
Study for Subjects With RelapsedRefractory Non-Hodgkin Lymphoma
Sponsor:
ImmunityBio Inc
Organization:
ImmunityBio Inc
Study Overview
Official Title:
Open-Label Phase 1 Study of CD19 t-haNK as a Single Agent and in Combination With Rituximab in Subjects With Selected CD19 and CD20 RelapsedRefractory B-Cell Non-Hodgkin Lymphoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
Open Label Phase 1 study of CD19 t-haNK as a single agent and combination with rituximab in subjects with selected CD19 and CD20 RR B-cell non-Hodgkin Lymphoma NHL
Detailed Description:
This is a phase 1 first-in-human FIH open-label study to evaluate the safety of CD19 t-haNK as a single agent and the safety and preliminary efficacy of CD19 t haNK in combination with rituximab in subjects with selected CD19 and CD20 RR B-cell non-Hodgkin lymphoma NHL
Up to 10 subjects will receive at least 1 dose of study drug The initial 3 subjects will receive study drug in a staggered fashion with a 7 day interval between each subject to evaluate any toxicities
Subjects will initially receive a single 3 week cycle of the CD19 t haNK as a single-agent regimen Following a 1-week safety pause subjects will then receive a 3 week cycle of CD19 t-haNK in combination with rituximab Subjects will then undergo the first tumor assessment Subjects with no evidence of progressive disease PD will be eligible to receive up to 2 additional 3 week cycles of CD19 t haNK in combination with rituximab
Up to 10 subjects will receive at least 1 dose of study drug The initial 3 subjects will receive study drug in a staggered fashion with a 7 day interval between each subject to evaluate any toxicities
Subjects will initially receive a single 3 week cycle of the CD19 t haNK as a single-agent regimen Following a 1-week safety pause subjects will then receive a 3 week cycle of CD19 t-haNK in combination with rituximab Subjects will then undergo the first tumor assessment Subjects with no evidence of progressive disease PD will be eligible to receive up to 2 additional 3 week cycles of CD19 t haNK in combination with rituximab
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