Ignite Creation Date:
2025-12-18 @ 9:17 AM
Ignite Modification Date:
2025-12-23 @ 8:39 PM
Study NCT ID:
NCT04627740
Status:
None
Last Update Posted:
2024-10-23 00:00:00
First Post:
2020-11-05 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anti-ALPP CAR-T Cells Immunotherapy for Advanced Solid Tumors
Sponsor:
None
Organization:
Study Overview
Official Title:
A Single-Arm, Single-Center, Open-Label Pilot Study of Anti-ALPP CART-cells in Patient With Alkaline Phosphatase, Placental (ALPP)-Positive Advanced Solid Tumor
Status:
None
Status Verified Date:
2024-10
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:
Primary Objectives:
To evaluate the number of ALPP-positive participants with treatment-related adverse events as assessed by CTCAE v4.0 after infusion with anti-ALPP CAR-T cells.
Secondary Objectives:
The number of patients experience objective response from anti-ALPP CAR-T cells treatment
To evaluate the progression-free survival (PFS) of anti-ALPP CAR-T cells in patients with ALPP-positive patients.
The number and percent of ALPP-CART cells in peripheral blood from ALPP-positive patients at 6 months after infusion
To evaluate the number of ALPP-positive participants with treatment-related adverse events as assessed by CTCAE v4.0 after infusion with anti-ALPP CAR-T cells.
Secondary Objectives:
The number of patients experience objective response from anti-ALPP CAR-T cells treatment
To evaluate the progression-free survival (PFS) of anti-ALPP CAR-T cells in patients with ALPP-positive patients.
The number and percent of ALPP-CART cells in peripheral blood from ALPP-positive patients at 6 months after infusion
Detailed Description:
None
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?: