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This is a single-arm, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, expansion, and persistence of functionally enhanced ALPP-targeted engineered T Cells (Herein referred to as Enhanced ALPP CAR-T) 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 Enhanced ALPP CAR-T 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced ALPP CAR-T | Experimental | Following lymphodepletion chemotherapy, participants will receive enhanced ALPP CAR-T cell infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced ALPP CAR-T treatment | Biological | Enhanced ALPP CAR-T cells Treatment follows a lymphodepletion Drug: Fludarabine and Cyclophosphamide. |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety of Enhanced ALPP CAR-T cells | The incidence, type, and severity of all adverse events, serious adverse events, and abnormal laboratory findings. | Up to 24 months |
| Safety of Enhanced ALPP CAR-T cells | Incidence of DLT | Up to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Enhanced ALPP CAR-T cells | Optimal objective response rate (ORR) | Up to 24 months |
| To investigate the Cmax of Enhanced ALPP CAR-T cells in the peripheral blood after infusion | To detect ALPP CAR copies in peripheral blood, then calculated Cmax. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tangfeng LV, MD | Contact | 02580863234 | njzyjg80863256@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Tangfeng Lv, MD | The Jinling Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Jinling Hospital | Recruiting | Nanjing | Jiangsu | China |
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|
| Up to 24 months |
| To assess Enhanced ALPP CAR-T cell trafficking into tumor tissues after infusion | To detect ALPP CAR-T cell number in tumor tissues after infusion | Up to 24 months |
| To investigate the AUC of Enhanced ALPP CAR-T cells in the peripheral blood after infusion | To detect ALPP CAR copies in peripheral blood, then calculated AUC. | Up to 24 months |