Clinical trial NCT04627740: Anti-ALPP CAR-T Cells Immunotherapy for Advanced Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Solid Tumors
Lead sponsor: Xinqiao Hospital of Chongqing
Sponsor class: OTHER
Collaborators: name: TCRCure Biopharma Ltd.
First posted: 2020-11-13
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients suffering treatment-related AE
timeFrame: 1 year
Secondary outcomes:
measure: Objective response rate to ALPP-CART infusion
timeFrame: Eight weeks
measure: Progression-free survival to ALPP-CART infusion
timeFrame: 6 months
measure: Number of peripheral CAR-T after infusion
timeFrame: 6 months
Other outcomes:
Locations:
city: ChongQing
country: China
facility: Department of Oncology, Xinqiao Hospital
state: Chongqing
Study officials:
References: