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

NCT07123493 | Terminated Early Phase 1

• 1 other identifier: A306-IIT-BJGB01
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent or Metastatic Solid Tumors With Positive ALPP

Keywords

CAR-T; Recurrent or metastatic solid tumors with positive ALPP

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Efficacy of ALPP CAR-T cells

  Up to 24 months

Other Outcomes (6)

• 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

Study Arms (1)

Anti-ALPP CAR-T Cell Therapy

EXPERIMENTAL

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

Interventions

Anti ALPP CAR-T cells treatment BIOLOGICAL

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

Anti-ALPP CAR-T Cell Therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must voluntarily provide written informed consent.
• Aged 18-70 years (inclusive).
• Life expectancy ≥ 3 months.
• ECOG performance status 0-1.
• Failed or unsuitable for standard therapy.
• At least one measurable lesion per RECIST 1.1.
• ALPP-positive tumor confirmed by immunohistochemistry.
• Adequate organ and bone marrow function.
• Effective contraception required for participants of childbearing potential.
• Adequate venous access for leukapheresis.

You may not qualify if:

• Primary CNS malignancy or uncontrolled CNS metastases.
• Other malignancies within 5 years (except adequately treated non-melanoma skin cancer or carcinoma in situ).
• Active autoimmune disease or history of autoimmune disease.
• Immunodeficiency, including HIV positivity.
• Bleeding disorders (inherited or acquired).
• Clinically significant cardiovascular disease.
• Active infection (including tuberculosis, hepatitis B/C, syphilis).
• Pregnant or breastfeeding women.
• History of refractory epilepsy, active GI bleeding, or high risk of tumor bleeding.
• Severe systemic or psychiatric illness.
• Prior cell or gene therapy.
• Severe drug hypersensitivity history.
• Investigator-assessed unsuitability for trial participation.

Sponsors & Collaborators

• Haifeng Qin: lead

Study Sites (1)

Beijing GoBroad Hospital

Beijing, Beijing Municipality, 102200, China

Location

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 14, 2025
• Study Start: August 28, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)