Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532643
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Safety and Efficacy of Anti-CD20CD30 CAR-T Cells in Subjects with RelapsedRefractory Lymphoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Exploratory Clinical Study of Autologous Anti-CD20CD30 Chimeric Antigen Receptor T Cells anti-CD20CD30 CAR-T Cells in Subjects with RelapsedRefractory 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 study is an exploratory clinical trial of a single-center open-label single-dose treatment of anti-CD20CD30-CAR-T cells in subjects with relapsedrefractory lymphoma
Detailed Description:
The study will enroll subjects with CD20 and CD30-positive lymphoma CD20-positive lymphoma or CD30-positive Hodgkin lymphoma Subjects will receive a single infusion of anti-CD20CD30-CAR-T cells after screening PBMC collection and lymphodepleting chemotherapy Toxicity will be assessed according to the Common Terminology Criteria for Adverse Events CTCAE version 50 from the National Cancer Institute Safety of anti-CD20CD30-CAR-T cell therapy will be evaluated through laboratory tests including 12-lead electrocardiograms vital sign checks etc Additionally blood samples will be collected from subjects to study cellular pharmacokinetics and explore the effects of cell therapy on ferritin C-reactive protein and related cytokines
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