Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06544265
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
SynKIR-310 for RelapsedRefractory B-NHL
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Study of SynKIR-310 Autologous T Cells Transduced with CD19 KIR-CAR in Participants with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
Status:
RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
This first-in-human FIH trial is designed to assess the safety feasibility and preliminary efficacy of a single intravenous IV dose of SynKIR-310 administered to participants with relapsedrefractory B-NHL
Detailed Description:
This is a Phase 1 FIH multicenter open-label study of a single infusion of SynKIR-310 in participants with relapsedrefractory B-NHL
Up to 18 participants regardless of subtypes of B-NHL who meet the eligibility criteria will be treated in the study
2 cohorts of 3 to 6 participants per cohort will be assessed to determine the safety and feasibility of treatment with SynKIR-310 Doses will be escalated across 2 cohorts to determine a Recommended Phase 2 Dose RP2D
Once the RP2D has been determined a dose expansion group will enroll additional participants regardless of subtypes of B-NHL at the RP2D to further characterize the safety feasibility and preliminary efficacy of SynKIR-310 in treating B-NHL
Up to 18 participants regardless of subtypes of B-NHL who meet the eligibility criteria will be treated in the study
2 cohorts of 3 to 6 participants per cohort will be assessed to determine the safety and feasibility of treatment with SynKIR-310 Doses will be escalated across 2 cohorts to determine a Recommended Phase 2 Dose RP2D
Once the RP2D has been determined a dose expansion group will enroll additional participants regardless of subtypes of B-NHL at the RP2D to further characterize the safety feasibility and preliminary efficacy of SynKIR-310 in treating B-NHL
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