Anti-ALPP CAR-T Cells Immunotherapy for Advanced Solid Tumors

Last updated: October 22, 2024
Sponsor: Xinqiao Hospital of Chongqing
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neoplasms

Ovarian Cancer

Solid Tumors

Treatment

Retroviral vector-transduced autologous T cells to express anti-ALPP CARs

Clinical Study ID

NCT04627740
TCRCureALPPCART
  • Ages 18-70
  • Female

Study Summary

The goal of this clinical trial is to evaluate the safety and efficacy of anti-ALPP chimeric antigen receptor (CAR)-modified T (CAR-T) cells in treating patients with ALPP-positive Advanced Solid Tumors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Expected to survive more than 3 months

  • PS 0-2

  • Immunohistochemistry was confirmed to be mesothelin positive ALPP (higher than 50%)

  • Patients with no curative regimen to receive

  • WBC>3.5×1e+9/L,Hb>90g/L,PLT>75×1e+9/L

  • HBV DNA copy number less than 100/ml

  • ALT≤5ULN, AST≤5ULN, TB≤1.5ULN, ALB≥35g/L

  • Understand this test and have signed informed consent

Exclusion

Exclusion Criteria:

  • Autoimmune diseases, or any uncontrolled active disease that hinders participationin the trial

  • Decompensated liver cirrhosis, liver function Child-pugh C grade

  • Portal vein tumor thrombus, arterial portal fistula, hepatic arteriovenous

  • Long-term use of immunosuppressive agents after organ transplantation

  • Screening indicated that the target cell transfection rate was less than 30%

  • Invasive pulmonary embolism, deep venous thrombosis, or other major arterial /venous thromboembolic events occurred 30 days or 30 days prior to randomization

  • Subjects had an active or uncontrollable infection requiring systemic therapy 14days or 14 days prior to randomization

  • Pregnant or lactating subjects

  • In the opinion of the investigator, the presence of a medical history or a historyof mental state may increase the number of subjects associated with the risk factorsassociated with the study or study drug administration

  • Subjects who have signed a written consent or who are in compliance with the studyprocedure; or who are unwilling or unable to comply with the study

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Retroviral vector-transduced autologous T cells to express anti-ALPP CARs
Phase: 1/2
Study Start date:
December 01, 2020
Estimated Completion Date:
May 31, 2025

Study Description

Primary Objectives:

To evaluate the number of ALPP-positive participants with treatment-related adverse events as assessed by CTCAE v4.0 after infusion with anti-ALPP CAR-T cells.

Secondary Objectives:

The number of patients experience objective response from anti-ALPP CAR-T cells treatment

To evaluate the progression-free survival (PFS) of anti-ALPP CAR-T cells in patients with ALPP-positive patients.

The number and percent of ALPP-CART cells in peripheral blood from ALPP-positive patients at 6 months after infusion

Connect with a study center

  • Department of Oncology, Xinqiao Hospital

    ChongQing, Chongqing 400037
    China

    Active - Recruiting

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