Engineered T-cell Therapy for Patients With ALPP-Positive Advanced Solid Tumors

A Single-Arm, Single-Center, Open-Label Pilot Study of Patients With ALPP-Positive Advanced Solid Tumors

Status

Terminated

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07108140

Enrollment

Registered

2025-08-06

Start date

2025-05-20

Completion date

2026-01-16

Last updated

2026-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumor

Keywords

Advanced Solid Tumor, ALPP, CAR-T

Brief summary

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.

Detailed description

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.

Interventions

BIOLOGICALAnti ALPP CAR-T cells treatment

anti ALPP CAR-T cells Treatment follows a lymphodepletion Drug: Fludarabine and Cyclophosphamide.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. Participants must voluntarily provide written informed consent. 2. Aged 18-70 years (inclusive). 3. Life expectancy ≥ 3 months. 4. ECOG performance status 0-1. 5. Failed or unsuitable for standard therapy. 6. At least one measurable lesion per RECIST 1.1. 7. ALPP-positive tumor confirmed by immunohistochemistry. 8. Adequate organ and bone marrow function. 9. Effective contraception required for participants of childbearing potential. 10. Adequate venous access for leukapheresis.

Exclusion criteria

1. Primary CNS malignancy or uncontrolled CNS metastases. 2. Other malignancies within 5 years (except adequately treated non-melanoma skin cancer or carcinoma in situ). 3. Active autoimmune disease or history of autoimmune disease. 4. Immunodeficiency, including HIV positivity. 5. Bleeding disorders (inherited or acquired). 6. Clinically significant cardiovascular disease. 7. Active infection (including tuberculosis, hepatitis B/C, syphilis). 8. Pregnant or breastfeeding women. 9. History of refractory epilepsy, active GI bleeding, or high risk of tumor bleeding. 10. Severe systemic or psychiatric illness. 11. Prior cell or gene therapy. 12. Severe drug hypersensitivity history. 13. Investigator-assessed unsuitability for trial participation.

Design outcomes

Primary

Measure	Time frame	Description
Safety of ALPP CAR-T cells	Up to 24 months	The incidence, type, and severity of all adverse events, serious adverse events, and abnormal laboratory findings.

Secondary

Measure	Time frame	Description
Efficacy of ALPP CAR-T cells	Up to 24 months]	Optimal objective response rate (ORR)

Countries

China

Contacts

PRINCIPAL_INVESTIGATORTangfeng Lv, MD

The Jinling Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026