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

A Single-Arm, Single-Center, Open-Label Pilot Study of Functionally Enhanced ALPP-Targeted Engineered T Cells for Patients With ALPP-Positive Advanced Solid Tumors

This trial will try an enhanced ALPP-targeted CAR-T cell therapy in adults with ALPP-positive recurrent or metastatic solid tumors that have progressed after prior treatments.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: TCRCure Biopharma Ltd. (industry)
• Drugs / interventions: CAR-T, chemotherapy
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT07487597 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–70 with ALPP-positive recurrent or metastatic solid tumors who have failed or are unsuitable for standard therapies, have ECOG 0–1, measurable disease, and adequate organ and bone marrow function are ideal candidates.

Not a fit: Patients with ALPP-negative tumors, uncontrolled CNS metastases, active infections, significant autoimmune disease, poor organ function, or pregnancy are unlikely to benefit and are excluded.

Why it matters

Potential benefit: If successful, this therapy could provide a new targeted immunotherapy option that shrinks or controls ALPP-positive solid tumors resistant to standard treatments.

How similar studies have performed: CAR-T therapies have transformed some blood cancers but have shown limited and mixed results in solid tumors, making ALPP-targeted CAR-T a relatively novel approach with limited prior clinical evidence.

Eligibility criteria

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 this trial is running

Nanjing, Jiangsu

• The Jinling Hospital — Nanjing, Jiangsu, China (RECRUITING)

Study contacts

• Principal investigator: Tangfeng Lv, MD — The Jinling Hospital
• Study coordinator: Tangfeng LV, MD

Conditions: Solid Tumor, Advanced Solid Tumor, ALPP, CAR-T