This is a single-arm, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, expansion, and persistence of ALPP CAR-T cells in patients with ALPP-positive recurrent or metastatic solid tumors who have progressed after prior therapies. The primary objective is to determine the maximum tolerated dose (MTD), with a secondary aim to assess preliminary clinical efficacy in solid tumors.
This study is designed as a single-arm, open-label, single-dose clinical trial to evaluate the safety and efficacy of ALPP CAR-T cell therapy in patients with recurrent or metastatic solid tumors. The study protocol consists of five main stages: (1) patient screening, (2) collection of peripheral blood mononuclear cells (PBMCs), (3) lymphodepletion chemotherapy, (4) ALPP CAR-T cell infusion, and (5) post-infusion follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
anti ALPP CAR-T cells Treatment follows a lymphodepletion Drug: Fludarabine and Cyclophosphamide.
The Jinling Hospital
Nanjing, Jiangsu, China
Safety of ALPP CAR-T cells
The incidence, type, and severity of all adverse events, serious adverse events, and abnormal laboratory findings.
Time frame: Up to 24 months
Safety of ALPP CAR-T cells
Incidence of DLT
Time frame: Up to 1 month
Efficacy of ALPP CAR-T cells
Optimal objective response rate (ORR)
Time frame: Up to 24 months]
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