Ignite Creation Date:
2024-05-06 @ 10:20 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03228667
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-29
First Post:
2017-07-21
Brief Title:
QUILT-3055 A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors
Sponsor:
ImmunityBio Inc
Organization:
ImmunityBio Inc
Study Overview
Official Title:
QUILT-3055 A Phase IIb Multicohort Open-Label Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With PD-1PD-L1 Immune Checkpoint Inhibitors
Status:
ACTIVE_NOT_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 is a Phase IIb multicohort open-label multicenter study of combination immunotherapies in patients who have previously received treatment with PD-1PD-L1 immune checkpoint inhibitors All patients in Cohorts 1-4 will receive the combination treatment of PD-1PD-L1 checkpoint inhibitor plus N-803 for up to 17 cycles Each cycle is six weeks in duration Some patients who experience disease progression while on study in Cohorts 1-4 may roll over into Cohort 5 and receive combination therapy with a PD-1PD-L1 checkpoint inhibitor N-803 and PD-L1 t-haNK cellular therapy for up to an additional 17 cycles Each cycle is six weeks in duration All patients will receive N-803 once every 3 weeks Patients will also receive the same checkpoint inhibitor that they received during their previous therapy Radiologic evaluation will occur at the end of each treatment cycle Treatment will continue for up to 2 years or until the patient experiences confirmed progressive disease or unacceptable toxicity withdraws consent or if the Investigator feels it is no longer in the patients best interest to continue treatment Patients will be followed for disease progression post-therapies and survival through 24 months past administration of the first dose of study drug
Detailed Description:
None
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