Ignite Creation Date:
2024-07-17 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06494371
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-06-18
Brief Title:
A Study of LCAR-HL30 in Subjects With RelapsedRefractory Hodgkins Lymphoma and Anaplastic Large Cell Lymphoma
Sponsor:
Ruijin Hospital
Organization:
Ruijin Hospital
Study Overview
Official Title:
An Open-label Clinical Study to Evaluate the Safety Tolerability and Efficacy of CD30-Targeted LCAR-HL30 Cells in Patients With RelapsedRefractory Hodgkins Lymphoma and Anaplastic Large Cell Lymphoma
Status:
RECRUITING
Status Verified Date:
2024-06
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 LCAR-HL30 in adult subjects with relapsedrefractory Hodgkins Lymphoma and Anaplastic Large Cell 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 LCAR-HL30 a chimeric antigen receptorCAR-T cell therapy in subjects with relapsedrefractory Hodgkins Lymphoma and Anaplastic Large Cell Lymphoma Patients who meet the eligibility criteria will receive LCAR-HL30 infusion The study will include the following sequential stages screening pre-treatment cell product preparation lymphodepleting chemotherapy treatment and follow-up
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