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

NCT04627740 | Completed Phase 1

• 1 other identifier: TCRCureALPPCART
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Objective response rate to ALPP-CART infusion

  Eight weeks

• Progression-free survival to ALPP-CART infusion

  6 months

• Number of peripheral CAR-T after infusion

  6 months

Study Arms (1)

CART treatment

EXPERIMENTAL

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

Interventions

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

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

CART treatment

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TCRCure Biopharma Ltd.: collaborator
• Xinqiao Hospital of Chongqing: lead

Study Sites (1)

Department of Oncology, Xinqiao Hospital

Chongqing, Chongqing Municipality, 400037, China

Location

Study Design

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

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 13, 2020
• Study Start: December 1, 2020
• Primary Completion: February 28, 2025
• Study Completion: August 31, 2025
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)