Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06556108
Status:
RECRUITING
Last Update Posted:
None
First Post:
2022-02-10
Brief Title:
ALPP CAR-T Cells for ALPP-Positive Advanced Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-Arm Single-Center Open-Label Pilot Study of Anti-ALPP CAR-T Cells for Alkaline Phosphatase Placental ALPP-Positive Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Alkaline phosphatase ALP is a membrane-bound glycoprotein that catalyzes the hydrolysis of phosphates at alkaline pH values As one of the earliest discovered oncofetal antigens ALP has emerged as a significant biomarker for various malignant tumors such as ovarian cancer breast cancer trophoblastic tumors germ cell tumors endometrial cancer testicular tumors cervical intraepithelial neoplasia and gastrointestinal tumors
Detailed Description:
This is a single-center open-label study of CAR-T cells for the treatment of the recurrentmetastatic solid tumors patients who had failed standard therapy
Objective
To evaluate the safety and efficacy of CAR-T cells in the treatment of advanced solid tumors
Eligibility
Adults aging 18-70 with advanced solid tumors
Design
1 Patients will undergo a comprehensive set of screening tests including imaging procedures evaluation of cardiac and pulmonary function as well as a range of laboratory assessments
2 After meeting the eligibility criteria and enrolling in the trial patients will undergo leukapheresis for collection of autologous lymphocytes which will be sent to manufacturing facilities
3 Once cells have been manufactured patients will then proceed to lymphodepleting chemotherapy followed by the infusion of ALPP CAR T-cells
Objective
To evaluate the safety and efficacy of CAR-T cells in the treatment of advanced solid tumors
Eligibility
Adults aging 18-70 with advanced solid tumors
Design
1 Patients will undergo a comprehensive set of screening tests including imaging procedures evaluation of cardiac and pulmonary function as well as a range of laboratory assessments
2 After meeting the eligibility criteria and enrolling in the trial patients will undergo leukapheresis for collection of autologous lymphocytes which will be sent to manufacturing facilities
3 Once cells have been manufactured patients will then proceed to lymphodepleting chemotherapy followed by the infusion of ALPP CAR T-cells
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None