Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT04556669
Status:
UNKNOWN
Last Update Posted:
2021-05-27
First Post:
2020-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anti-PD-L1 Armored Anti-CD22 CAR-T/CAR-TILs Targeting Patients With Solid Tumors
Sponsor:
Hebei Senlang Biotechnology Inc., Ltd.
Organization:
Study Overview
Official Title:
Feasibility and Safety of Anti-PD-L1 Armored Anti-CD22 CAR-T/CAR-TILs Targeting Patients With Solid Tumors
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
RECRUITING
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 an open-labeled, single-armed and prospective study, patients with advanced malignant solid tumors will be given with SL22P autologous CAR - T/CAR-TILs cells. The aim of the study is to evaluate the safety and efficacy of SL22P CAR-T cells, including the adverse reaction, pharmacokinetics, and the outcomes of patients.
Detailed Description:
SL22P is a proprietary product of Senlang Biotechnology. The T cells may be isolated from the peripheral blood or from the tumor tissue. The CAR-T/CAR-TILs cells contains a anti-CD22 CAR structure and also carries a scFv fragment of anti-PD-L1 monoclonal antibody. After autologous SL22P CAR-T/CAR-TILs cells were transplanted back into patients, CAR-T would target CD22+B cells in the blood. This will promote the activation and amplification of CAR+ cells, and secrete anti-PD-L1 scFv outside the cells to regulate the immunity and enhance anti-tumor activity. The CAR-TILs may reduce the severity of the adverse reactions than conventional TILs, which result from the combination of high dose IL-2 infusion.
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?:
None
Is an FDA AA801 Violation?: