Solid Tumors
Conditions
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
Interventions
DRUGRetroviral 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
Sponsors
Xinqiao Hospital of Chongqing
TCRCure Biopharma Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients suffering treatment-related AE | 1 year | 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
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate to ALPP-CART infusion | Eight weeks | The number of patients experience objective response from anti-ALPP CAR-T cells treatment |
| Progression-free survival to ALPP-CART infusion | 6 months | To evaluate the progression-free survival (PFS) of anti-ALPP CAR-T cells in patients with mesothelin-positive advanced ovarian carcinoma. |
| Number of peripheral CAR-T after infusion | 6 months | The number of ALPP-CART cells in peripheral blood from ALPP-positive patients at 6 months after infusion |
Countries
China
Outcome results
None listed