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

Army Medical University of People's Liberation Army

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Solid Tumors

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04627740

TCRCureALPPCART

Details and patient eligibility

About

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.

Full 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

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

CART treatment

Experimental group

Description:

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

Treatment:

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