Enhanced ALPP-targeted CAR-T therapy for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-arm, open-label, early Phase 1 dose-escalation study administers a single infusion of functionally enhanced ALPP-targeted CAR-T cells to patients with ALPP-positive recurrent or metastatic solid tumors. Participants undergo screening, leukapheresis to collect peripheral blood mononuclear cells, lymphodepletion chemotherapy, CAR-T infusion, and scheduled post-infusion follow-up for safety and response monitoring. The primary objective is to determine the maximum tolerated dose and characterize safety and tolerability, while secondary endpoints include CAR-T expansion, persistence, and preliminary tumor response by RECIST 1.1. Eligible adults are treated at The Jinling Hospital in Nanjing and are followed for safety and efficacy outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Jinling Hospital
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Tangfeng Lv, MD — The Jinling Hospital
• Study coordinator: Tangfeng LV, MD
• Email: njzyjg80863256@163.com
• Phone: 02580863234

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.