Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06539338
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-19
Brief Title:
Safety of INT2104 in Participants Aged 18 Years and Older Who Have B-cell Cancer That Came Back After Prior Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Two-Part Open Label Phase 1 Multicentre Study Evaluating the Safety of INT2104 Infusions in Female and Male Participants Aged 18 Years of Age and Older With RefractoryRelapsing B-cell Malignancies
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INVISE
Brief Summary:
The purpose of this first-in-human study is to evaluate the safety of INT2104 when administered to humans in a broad population of participants with refractoryrelapsing B-cell malignancies Preliminary efficacy information may also be obtained
INT2104 is a gene therapy delivering a transgene for a chimeric antigen receptor CAR specific for CD20 CAR20 The lentiviral vector is designed to generate CAR T and CAR Natural Killer NK cells inside the body following intravenous IV administration
Study details include the following
The study duration will be 5 years
The treatment duration will be a one-time intravenous IV infusion of INT2104
INT2104 is a gene therapy delivering a transgene for a chimeric antigen receptor CAR specific for CD20 CAR20 The lentiviral vector is designed to generate CAR T and CAR Natural Killer NK cells inside the body following intravenous IV administration
Study details include the following
The study duration will be 5 years
The treatment duration will be a one-time intravenous IV infusion of INT2104
Detailed Description:
This is a non-randomized open label multi-site Phase 1 First in Human FIH study split into two parts The first part Part A is a dose escalation and the second part Part B will be to confirm the dose
The aim of the study is to collect data to assess whether the study product INT2104 is safe and tolerable to understand how well INT2104 works in the human body and to select the dose to take into a Phase 2 study
All participants will receive one intravenous IV infusion of INT2104
Each participant in the study will follow the same study treatment schedule and will proceed through the following study periods
Screening Period participant will be assessed for eligibility
Study Day 1 participants who meet all eligibility criteria will receive INT2104 by a one-time infusion
Post-treatment Assessment Period participants will be followed regularly with clinic visits after they receive INT2104
The aim of the study is to collect data to assess whether the study product INT2104 is safe and tolerable to understand how well INT2104 works in the human body and to select the dose to take into a Phase 2 study
All participants will receive one intravenous IV infusion of INT2104
Each participant in the study will follow the same study treatment schedule and will proceed through the following study periods
Screening Period participant will be assessed for eligibility
Study Day 1 participants who meet all eligibility criteria will receive INT2104 by a one-time infusion
Post-treatment Assessment Period participants will be followed regularly with clinic visits after they receive INT2104
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None