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

NCT07108140 | Terminated Early Phase 1

• 1 other identifier: ALPP-NJ002
• Study Type: interventional
• Target: 5
• 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

Solid Tumor

Keywords

Advanced Solid Tumor; ALPP; CAR-T

Outcome Measures

Primary Outcomes (2)

• Safety of ALPP CAR-T cells

  The incidence, type, and severity of all adverse events, serious adverse events, and abnormal laboratory findings.

  Up to 24 months

• Safety of ALPP CAR-T cells

  Incidence of DLT

  Up to 1 month

Secondary Outcomes (1)

• Efficacy of ALPP CAR-T cells

  Up to 24 months]

Other Outcomes (3)

• To investigate the Cmax of ALPP CAR-T cells in the peripheral blood after infusion

  Up to 24 months

• To assess ALPP CAR-T cell trafficking into tumor tissues after infusion

  Up to 24 months

• To investigate the AUC of ALPP CAR-T cells in the peripheral blood after infusion

  Up to 24 months

Study Arms (1)

Anti-ALPP CAR-T Cell Therapy

EXPERIMENTAL

Following lymphodepletion chemotherapy, participants will receive anti-ALPP CAR-T cell infusion.

Biological: Anti ALPP CAR-T cells treatment

Interventions

Anti ALPP CAR-T cells treatment BIOLOGICAL

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

Also known as: Fludarabine 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

• TCRCure Biopharma Ltd.: lead
• Nanjing University School of Medicine: collaborator

Study Sites (1)

The Jinling Hospital

Nanjing, Jiangsu, China

Location

Study Officials

• Tangfeng Lv, MD

  The Jinling Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 6, 2025
• Study Start: May 20, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 16, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

CN (1)