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

NCT ID: NCT07123493

Last Updated: 2026-01-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-28
• Study Completion Date: 2025-12-30

Brief Summary

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.

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.

Conditions

Recurrent or Metastatic Solid Tumors With Positive ALPP

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Anti ALPP CAR-T cells treatment

Intervention Type: BIOLOGICAL

Biological: anti ALPP CAR-T cells Treatment follows a lymphodepletion Drug: Fludarabine and Cyclophosphamide

Interventions

Anti ALPP CAR-T cells treatment

Biological: anti ALPP CAR-T cells Treatment follows a lymphodepletion Drug: Fludarabine and Cyclophosphamide

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haifeng Qin

OTHER

Sponsor Role: lead

Responsible Party

Haifeng Qin

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Beijing GoBroad Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

A306-IIT-BJGB01

Identifier Type: -

Identifier Source: org_study_id