Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06364852
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-01-08
Brief Title:
An Evaluation of LY007 Cell Injection for rr B-NHL
Sponsor:
Ruijin Hospital
Organization:
Ruijin Hospital
Study Overview
Official Title:
An Evaluation of LY007 Cell Injection for RecurrentRefractory CD20 Was Positive Tolerability Safety and Efficacy of B-cell Non-Hodgkin Lymphoma in Open Single-arm Stage I Clinical Research
Status:
RECRUITING
Status Verified Date:
2024-04
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:
rr B-NHL
Brief Summary:
An evaluation of LY007 cell injection for recurrentrefractory CD20 was positive Tolerability safety and efficacy of B-cell non-Hodgkin lymphoma in open single-arm Phsea I Clinical research
Detailed Description:
This is a phase I single-arm open 33 dose escalation study to evaluate the efficacy of LY007 cell injection Safety tolerability PK characteristics PD characteristics initial efficacy and immunogenicity
This study plans to enroll approximately 9-18 subjects with relapsedrefractory CD20-positive B-NHL including DLBCL inclusive Histological transformation and TFL The number of subjects ultimately enrolled depends on the number of DLT observed during the dose escalation phase The number of incremental dose groups prior to DLT and the determination of MTD or clinically recommended dose
This study plans to enroll approximately 9-18 subjects with relapsedrefractory CD20-positive B-NHL including DLBCL inclusive Histological transformation and TFL The number of subjects ultimately enrolled depends on the number of DLT observed during the dose escalation phase The number of incremental dose groups prior to DLT and the determination of MTD or clinically recommended dose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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