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Recruiting Early Phase 1

Functionally Enhanced ALPP-Targeted Engineered T Cells in Advanced Solid Tumors

NCT07487597 · tracked via the Priya Life Science China tracker
Phase
Early Phase 1
Started
2026-02-28
Last updated
2026-03-23

Condition(s) studied

Solid Tumor

Investigational drug(s) / intervention(s)

Enhanced ALPP CAR-T treatment

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

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Safety of Enhanced ALPP CAR-T cells — Up to 24 months
    The incidence, type, and severity of all adverse events, serious adverse events, and abnormal laboratory findings.
  • Safety of Enhanced ALPP CAR-T cells — Up to 1 month
    Incidence of DLT

Trial sites (1)

FacilityCityRegionStatus
The Jinling Hospital Nanjing Jiangsu Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07487597 on ClinicalTrials.gov ↗ ← All trials in China