Ignite Creation Date:
2025-12-24 @ 12:01 PM
Ignite Modification Date:
2026-01-01 @ 7:55 PM
Study NCT ID:
NCT06375161
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-CD19-CAR-T Cells in Relapsed/Refractory B-cell Tumor Patients.
Sponsor:
Shanghai Tongji Hospital, Tongji University School of Medicine
Organization:
Study Overview
Official Title:
An Exploratory Clinical Study Evaluating the Safety and Efficacy of Infusion of Anti-CD19-CAR-T Cells in Relapsed/Refractory 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 relapsed/refractory B-cell tumor patients after Qinglin pre-treatment.
In this study phase, a traditional "3+3" trial design is employed for dose escalation.
In this study phase, a traditional "3+3" trial design is employed for dose escalation.
Detailed Description:
The study plans to include CD19-positive relapsed/refractory 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 5.0). 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 5.0). 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:
True
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?: