Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06375161
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-16
Brief Title:
Anti-CD19-CAR-T Cells in RelapsedRefractory B-cell Tumor Patients
Sponsor:
Shanghai Tongji Hospital Tongji University School of Medicine
Organization:
Shanghai Tongji Hospital Tongji University School of Medicine
Study Overview
Official Title:
An Exploratory Clinical Study Evaluating the Safety and Efficacy of Infusion of Anti-CD19-CAR-T Cells in RelapsedRefractory B-cell Tumor Patients
Status:
RECRUITING
Status Verified Date:
2023-08
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:
None
Brief Summary:
This study is a single-center open-label single-dose clinical trial of anti-CD19-CAR-T cell therapy in relapsedrefractory B-cell tumor patients after Qinglin pre-treatment
In this study phase a traditional 33 trial design is employed for dose escalation
In this study phase a traditional 33 trial design is employed for dose escalation
Detailed Description:
The study plans to include CD19-positive relapsedrefractory B-cell tumor patients After the screening period peripheral blood mononuclear cell PBMC collection and lymphocyte depletion pre-treatment period subjects will receive a single infusion of anti-CD19-CAR-T cells In addition to the baseline period efficacy assessments will be conducted monthly for ALL subjects and at weeks 4 12 24 36 and 48 post-treatment for NHL subjects until disease progression PD relapse change of treatment regimen death intolerable toxicity at the discretion of the investigator or voluntary withdrawal by the patient whichever occurs first
Toxicity will be evaluated according to the Common Terminology Criteria for Adverse Events CTCAE version 50 Safety of anti-CD19-CAR-T cell therapy will be evaluated through laboratory tests 12-lead electrocardiograms vital signs physical examinations etc Blood samples will be collected from subjects to assess cellular pharmacokinetics and explore the effects of cellular drugs on ferritin C-reactive protein and related cytokines
Toxicity will be evaluated according to the Common Terminology Criteria for Adverse Events CTCAE version 50 Safety of anti-CD19-CAR-T cell therapy will be evaluated through laboratory tests 12-lead electrocardiograms vital signs physical examinations etc Blood samples will be collected from subjects to assess cellular pharmacokinetics and explore the effects of cellular drugs on ferritin C-reactive protein and related cytokines
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