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Recruiting NCT07487597

Functionally Enhanced ALPP-Targeted Engineered T Cells in Advanced Solid Tumors

Early Phase I Interventional Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Enhanced ALPP CAR-T treatment.
Who it may be relevant to
Registry conditions: Solid Tumor. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • Biological Enhanced ALPP CAR-T treatment
    Enhanced ALPP CAR-T cells Treatment follows a lymphodepletion Drug: Fludarabine and Cyclophosphamide.

Primary outcome measures

  • Safety of Enhanced ALPP CAR-T cells [Time frame: Up to 24 months]
  • Safety of Enhanced ALPP CAR-T cells [Time frame: Up to 1 month]
Secondary outcome measures (4)
  • Efficacy of Enhanced ALPP CAR-T cells [Time frame: Up to 24 months]
  • To investigate the Cmax of Enhanced ALPP CAR-T cells in the peripheral blood after infusion [Time frame: Up to 24 months]
  • To assess Enhanced ALPP CAR-T cell trafficking into tumor tissues after infusion [Time frame: Up to 24 months]
  • To investigate the AUC of Enhanced ALPP CAR-T cells in the peripheral blood after infusion [Time frame: Up to 24 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The Jinling Hospital — Nanjing

Identifiers

NCT: NCT07487597 · ALPP-NJ003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗