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

A Single-Arm, Single-Center, Open-Label Pilot Study of Anti-ALPP CART-cells in Patient With Alkaline Phosphatase, Placental (ALPP)-Positive Advanced Solid Tumor

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.

Study Overview

• Status: Completed
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: Retroviral vector-transduced autologous T cells to express anti-ALPP CARs

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400037
      • Department of Oncology, Xinqiao Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Criteria:

• Autoimmune diseases, or any uncontrolled active disease that hinders participation in 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 14 days or 14 days prior to randomization
• Pregnant or lactating subjects
• In the opinion of the investigator, the presence of a medical history or a history of mental state may increase the number of subjects associated with the risk factors associated with the study or study drug administration
• Subjects who have signed a written consent or who are in compliance with the study procedure; or who are unwilling or unable to comply with the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CART treatment; Cyclophosphamide will be administered at dose of 20mg/kg for 1 day and then fludarabine will be given for the next 3 days with 35mg/m2 and then the CAR-T cells will be administered	Drug: Retroviral vector-transduced autologous T cells to express anti-ALPP CARs; Cyclophosphamide will be administered at dose of 20mg/kg for 1 day and then fludarabine will be given for the next 3 days with 35mg/m2 and then the CAR-T cells will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients suffering treatment-related AE	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate to ALPP-CART infusion	The number of patients experience objective response from anti-ALPP CAR-T cells treatment	Eight weeks
Progression-free survival to ALPP-CART infusion	To evaluate the progression-free survival (PFS) of anti-ALPP CAR-T cells in patients with mesothelin-positive advanced ovarian carcinoma.	6 months
Number of peripheral CAR-T after infusion	The number of ALPP-CART cells in peripheral blood from ALPP-positive patients at 6 months after infusion	6 months

Collaborators and Investigators

• Sponsor: Xinqiao Hospital of Chongqing
• Collaborators: TCRCure Biopharma Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): August 31, 2025

Study Registration Dates

• First Submitted: November 5, 2020
• First Submitted That Met QC Criteria: November 11, 2020
• First Posted (Actual): November 13, 2020

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Neoplasms
• Other Study ID Numbers: TCRCureALPPCART

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No