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

Not Applicable

Not yet recruiting

• Conditions: Recurrent or Metastatic Solid Tumors With Positive ALPP
• Interventions: Biological: Anti ALPP CAR-T cells treatment

• Registration Number: NCT07123493
• Lead Sponsor: Haifeng Qin

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.

Study Timeline

• Study First Submitted: 2025-07-21
• Status Verified: 2025-08
• Study Start: 2025-08-01
• Study First Submitted QC: 2025-08-07
• Last Update Submitted: 2025-08-07
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-14
• Primary Completion: 2026-08
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anti-ALPP CAR-T Cell Therapy	Anti ALPP CAR-T cells treatment	Biological: Anti-ALPP CAR-T Cells Following lymphodepletion chemotherapy, participants will receive anti-ALPP CAR-T cell infusion. Drug: Fludarabine Drug: Cyclophosphamide

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Efficacy of ALPP CAR-T cells	Up to 24 months	Optimal objective response rate (ORR)

Trial Locations

Locations (1)

Beijing GoBroad Hospital; 🇨🇳 Beijing, Beijing, China