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

A Single-Arm, Single-Center, Open-Label Clinical Trial of Engineered T-Cell Therapy in Patients With ALPP-Positive Recurrent or Metastatic Solid Tumors

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.

Study Overview

• Status: Terminated
• Conditions: Recurrent or Metastatic Solid Tumors With Positive ALPP
• Intervention / Treatment: Biological: Anti ALPP CAR-T cells treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 102200
      • Beijing GoBroad Hospital

Participation Criteria

Eligibility Criteria

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

Description

Key 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.

Key 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: Anti-ALPP CAR-T Cell Therapy; Biological: Anti-ALPP CAR-T Cells Following lymphodepletion chemotherapy, participants will receive anti-ALPP CAR-T cell infusion. Drug: Fludarabine Drug: Cyclophosphamide	Biological: Anti ALPP CAR-T cells treatment; Biological: anti ALPP CAR-T cells Treatment follows a lymphodepletion Drug: Fludarabine and Cyclophosphamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events of ALPP CAR-T cells [Safety and Tolerability]	The incidence, type, and severity of all adverse events, serious adverse events, and abnormal laboratory findings.	Up to 24 months
Incidence of Dose Limiting Toxicity of ALPP CAR-T cells [Safety and Tolerability]	Incidence of Dose Limiting Toxicity	Up to 1 month

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Cmax of ALPP CAR-T cells	Up to 24 months
Tmax of ALPP CAR-T cells	Up to 24 months
AUC0-last of ALPP CAR-T cells	Up to 24 months
Clast of ALPP CAR-T cells	Up to 24 months
Tlast of ALPP CAR-T cells	Up to 24 months
To assess ALPP CAR-T cell trafficking into tumor tissues following infusion【To detect ALPP CAR-T cell number in tumor tissues after infusion】	Up to 24 months

Collaborators and Investigators

• Sponsor: Haifeng Qin

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2025
• Primary Completion (Actual): December 30, 2025
• Study Completion (Actual): December 30, 2025

Study Registration Dates

• First Submitted: July 21, 2025
• First Submitted That Met QC Criteria: August 7, 2025
• First Posted (Actual): August 14, 2025

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: CAR-T; Recurrent or metastatic solid tumors with positive ALPP
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Recurrence
• Other Study ID Numbers: A306-IIT-BJGB01

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