ALPP CAR-T Cells for ALPP-Positive Advanced Solid Tumors
NCT Number: NCT06556108
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Advanced Solid Tumors
Interventions: BIOLOGICAL: ALPP CAR-T cells|DRUG: Fludarabine|DRUG: Cyclophosphamide
Sponsor: Xinqiao Hospital of Chongqing
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 9
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-01-01
Completion Date: 2026-01-30
Locations: Department of Hematology, Xinqiao Hospital, ChongQing, Chongqing, 400037, China

Summary:
Alkaline phosphatase (ALP) is a membrane-bound glycoprotein that catalyzes the hydrolysis of phosphates at alkaline pH values. As one of the earliest discovered oncofetal antigens, ALP has emerged as a significant biomarker for various malignant tumors, such as ovarian cancer, breast cancer, trophoblastic tumors, germ cell tumors, endometrial cancer, testicular tumors, cervical intraepithelial neoplasia, and gastrointestinal tumors.

Primary Outcome Measures: Dose Limiting Toxicity or Maximum Tolerated Dose (MTD), Dose Limiting Toxicity (DLT) is defined as patients with the adverse event (AE) or laboratory abnormality assessed by the principal investigator (PI). These should be possibly related to ALPP CAR-T cell therapy, and should be unrelated to the disease itself, disease progression, concomitant diseases or concomitant medication. The MTD is the highest dose at which no more than one out of six patients experiences DLT, or the highest dose level tested if no DLTs are observed across all dose levels., Day 28 post-initial ALPP CAR-T infusion|Overall response rate, The efficacy of ALPP CAR-T is assessed by the objective response rate (ORR) according to RECIST 1.1 and iRECIST. ORR is defined as patients who have achieved either a partial response (PR) or a complete response (CR)., Day 0 - Day 730|Treatment-related adverse events as assessed by CTCAE v5.0, The type, incidence and severity of adverse events include clinically significant post-treatment abnormal laboratory examination results, abnormal physical examination and blood examination results, bone marrow examination results, etc. Clinical and laboratory AEs will be classified according to the National Cancer Institute general terminology standard for adverse events (NCI CTCAE) version 5.0., Day 0 - Day 730
Secondary Outcome Measures: Duration of response, The efficacy of ALPP CAR-T will be assessed by duration of response (DOR). The DOR refers to the length of time from the first appearance of a treatment response to the first occurrence of progressive disease or recurrence., Day 0 - Day 730|Progression free survival, The efficacy of ALPP CAR-T will be assessed by progression free survival (PFS). The PFS refers to the time from treatment to progressive disease or death for any reason., Day 0 - Day 730|Overall survival, The efficacy of ALPP CAR-T will be assessed by overall survival (OS). The OS refers to the time from treatment to death., Day 0 - Day 730|Expansion and persistence of ALPP CAR-T cells in peripheral blood or serous effusion (if present), Blood and serous effusion (if present) samples were collected to measure persistence of infused ALPP CAR-T using polymerase chain reaction of a vector specific sequence in deoxyribonucleic acid (DNA) extracted from peripheral blood mononuclear cell (PBMC)., Day 0 - Day 730|Cell cytokine levels and tumor biomarkers in peripheral blood and serous effusion (if present), Blood samples and serous effusion (if present) were collected to measure cytokines IL-6, TNF-α, IL-8, IFN-γ, C-reactive protein (CRP), as well as ALPP concentration, Alpha-fetoprotein (AFP), Human chorionic gonadotropin (hCG), etc., Day 0 - Day 730