NCT06556108

ALPP CAR-T Cells for ALPP-Positive Advanced Solid Tumors

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: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Xinqiao Hospital of Chongqing · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 recurrent/metastatic 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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	ALPP CAR-T cells	T cells genetically engineered with a CAR targeting ALPP (ALPP CAR) that display specific reactivity against ALPP target cells
DRUG	Fludarabine	Part of the non-myeloablative lymphocyte-depleting preparative regimen.
DRUG	Cyclophosphamide	Part of the non-myeloablative lymphocyte-depleting preparative regimen.

Timeline

• Start date: 2018-01-01
• Primary completion: 2025-01-30
• Completion: 2025-07-30
• First posted: 2024-08-15
• Last updated: 2026-01-20

Locations

1 site across 1 country: China