Ignite Creation Date:
2024-10-25 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06519344
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
An Exploratory Clinical Study Evaluating the Safety and Efficacy of Intravenous Anti-CD20CD30-CAR-T Cell Infusion in RelapsedRefractory Lymphoma Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Exploratory Clinical Study Evaluating the Safety and Efficacy of Intravenous Anti-CD20CD30-CAR-T Cell Infusion in RelapsedRefractory Lymphoma Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 a single-centeropen-labelsingle-dose clinical trial of anti-CD20CD30-CAR-T cell therapy in relapsedrefractory B-cell tumor patients after lymphocyte depletion pre-treatment
In this study phasea traditional 33trial design is employed for dose escalation
In this study phasea traditional 33trial design is employed for dose escalation
Detailed Description:
This study is a single-center open-label single-dose clinical trial of anti-CD20CD30-CAR-T cell therapy in relapsedrefractory lymphoma patients after lymphocyte depletion pre-treatment
The study aims to include patients with CD20CD30 double-positive relapsedrefractory lymphomas CD20-positive relapsedrefractory B-cell lymphomas including patients who have relapsed after anti-CD19-CAR-T cell therapy and CD30-positive Hodgkin lymphoma Participants will undergo screening peripheral blood mononuclear cell PBMC collection and lymphocyte depletion pre-treatment before receiving a single infusion of anti-CD20CD30-CAR-T cells
Throughout the study efficacy assessments will occur at baseline and at 4 weeks post-treatment and subsequently at 3 months 6 months 9 months and 12 months until disease progression PD relapse change of treatment regimen death intolerable toxicity investigator decision or voluntary withdrawal whichever comes first
Safety evaluations of anti-CD20CD30-CAR-T cell therapy will be conducted according to the Common Terminology Criteria for Adverse Events CTCAE version 50 by laboratory tests 12-lead electrocardiograms vital signs and physical examinations Additionally blood samples will be collected to assess cellular pharmacokinetics and explore the effects of cellular therapy on ferritin C-reactive protein and related cytokines
The study is designed as an exploratory research project subject to implementation conditions at the research center Dose escalation during this study phase will follow a traditional 33 trial design
The study aims to include patients with CD20CD30 double-positive relapsedrefractory lymphomas CD20-positive relapsedrefractory B-cell lymphomas including patients who have relapsed after anti-CD19-CAR-T cell therapy and CD30-positive Hodgkin lymphoma Participants will undergo screening peripheral blood mononuclear cell PBMC collection and lymphocyte depletion pre-treatment before receiving a single infusion of anti-CD20CD30-CAR-T cells
Throughout the study efficacy assessments will occur at baseline and at 4 weeks post-treatment and subsequently at 3 months 6 months 9 months and 12 months until disease progression PD relapse change of treatment regimen death intolerable toxicity investigator decision or voluntary withdrawal whichever comes first
Safety evaluations of anti-CD20CD30-CAR-T cell therapy will be conducted according to the Common Terminology Criteria for Adverse Events CTCAE version 50 by laboratory tests 12-lead electrocardiograms vital signs and physical examinations Additionally blood samples will be collected to assess cellular pharmacokinetics and explore the effects of cellular therapy on ferritin C-reactive protein and related cytokines
The study is designed as an exploratory research project subject to implementation conditions at the research center Dose escalation during this study phase will follow a traditional 33 trial design
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