Functionally Enhanced ALPP-Targeted Engineered T Cells in 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 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.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Biological: Enhanced ALPP CAR-T treatment

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Tangfeng Lv, MD; Phone Number: 02580863234; Email: njzyjg80863256@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • The Jinling Hospital
      • Contact: Tangfeng Lv, MD; Phone Number: 02580863234; Email: njzyjg80863256@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enhanced ALPP CAR-T; Following lymphodepletion chemotherapy, participants will receive enhanced ALPP CAR-T cell infusion.	Biological: Enhanced ALPP CAR-T treatment; Enhanced ALPP CAR-T cells Treatment follows a lymphodepletion Drug: Fludarabine and Cyclophosphamide.; Other Names: Fludarabine Cyclophosphamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: TCRCure Biopharma Ltd.
• Investigators: Principal Investigator: Tangfeng Lv, MD, The Jinling Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2029

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 23, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: CAR-T; Advanced Solid Tumor; ALPP
• Other Study ID Numbers: ALPP-NJ003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No