Study design and patients
hepatitis B, death, Tumors, clear cell sarcoma, human immunodeficiency virus, 14–70, autoimmune diseases or syndrome, ASPS
DISORDER, ACTIVE TUBERCULOSIS, ALVEOLAR SOFT PART SARCOMA, HEPATITIS B, HUMAN IMMUNODEFICIENCY VIRUS, SARCOMAS, BRAIN METASTASES, RECRUITMENT, TUMORS, SARCOMA, CLEAR CELL SARCOMA, HEPATITIS C, ONCOLOGY, SOFT TISSUE AND BONE TUMOR, SYPHILIS INFECTION, METASTASES, BONE METASTASES
MASCT-I-1005 was a single-center, open-label, 2-part, phase 1 trial (clinicaltrials.gov, NCT04074564). Part A assessed the safety and efficacy of two administration schedules for MASCT-I when combined with camrelizumab and apatinib at fixed doses in patients with advanced bone and soft-tissue sarcomas, and part B further assessed MASCT-I (using the schedule selected based on part A) in combination with apatinib at fixed dose. Here, we report the findings in part A.Eligible patients were 14–70 years of age; had histologically and cytologically confirmed unresectable recurrent or metastatic bone and soft-tissue sarcoma according to the World Health Organization Classification of Soft Tissue and Bone Tumors; had progressed on at least one line of anti-tumor therapy (such as anthracycline-based chemotherapy or VEGFR-TKI) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (for alveolar soft part sarcoma [ASPS] and clear cell sarcoma patients, no prior treatment was allowed for recruitment as no standard treatment existed; for patients with metastases, the maximum diameter should be no more than 8 cm); had at least one measurable lesion per RECIST version 1.1; had an Eastern Cooperative Oncology Group (ECOG) performance status of 0–1 (for amputees, performance status of 2 was allowed for recruitment); had a life expectancy of at least 6 months; had adequate cardio-pulmonary function; and had adequate hematological, hepatic, and renal function. The key exclusion criteria included active bone metastases or brain metastases; active or history of autoimmune diseases or syndrome, or requiring chronic use of steroids, immunomodulators or immunosuppressive drugs within 2 weeks before study entry; anti-tumor therapies such as chemotherapy, radiation therapy, or targeted therapy within 4 weeks prior to study entry; prior treatment with MASCT, other cellular immunotherapy, or antibodies against PD-1, programmed cell death ligand 1 (PD-L1), or cytotoxic T lymphocyte-associated antigen-4 within the past 1 year; uncontrolled medical disorder (including active tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus, or syphilis infection); and being pregnant or planning to be pregnant.