Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2025-12-26 @ 3:14 AM
Study NCT ID:
NCT06313957
Status:
RECRUITING
Last Update Posted:
2025-03-25
First Post:
2024-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of LUCAR-20SP in Subjects With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Sponsor:
Peking University Cancer Hospital & Institute
Organization:
Study Overview
Official Title:
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LUCAR-20SP, an Allogenic Chimeric Antigen Receptor(CAR)-T Cell Therapy Targeting CD20 in Subjects With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Status:
RECRUITING
Status Verified Date:
2025-03
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 is a prospective, single-arm, open-label, exploratory clinical study of LUCAR-20SP in adult subjects with relapsed/refractory B-cell non-Hodgkin lymphoma.
Detailed Description:
This is a prospective, single-arm, open-label exploratory clinical study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor efficacy profiles of LUCAR-20SP, an allogenic CAR-T cell therapy in subjects with relapsed/refractory B-cell non-Hodgkin lymphoma. Patients who meet the eligibility criteria will receive LUCAR-20SP infusion. The study will include the following sequential stages: screening, pre-treatment (lymphodepleting chemotherapy), treatment and follow-up.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: