This Phase 1, first-in-human (FIH), open-label study is designed to assess the safety, tolerability, and preliminary clinical efficacy of repeated intravenous (IV) infusions of SUPLEXA monotherapy in subjects with measurable metastatic solid tumours and haematologic malignancies
This is a FIH Phase 1, non-comparative, open-label, basket-design study. The study will consist of 2 cohorts: * Solid tumours cohort * Haematologic malignancies cohort: Subjects must fulfill entry criteria and have relapsed or refractory advanced malignancy for which no standard therapy exists. An Data Safety Monitoring Committee (DSMB) will provide oversight of the study and will monitor safety on a regular basis throughout the study to make recommendations on any modifications. The study will be comprised of 3 periods. Screening, Treatment and Follow-up. All eligible subjects will receive minimally 3 weekly dosing of SUPLEXA. Subjects will be monitored closely at the clinic after each weekly infusion. After completion of the first 3 weekly SUPLEXA the treatment period of SUPLEXA may be extended to every 2 weeks until all SUPLEXA is depleted.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
PBMC-derived autologous cellular therapy derived through an ex vivo activation procedure, resulting in a cell mixture comprised predominantly of NK, NK-T, and T cells stored in cryogenic media.
Greenslopes Private Hospital/Gallipoli Medical Research Foundation
Brisbane, Queeensland, Australia
Cancer Research Sa (Crsa)
Adelaide, South Australia, Australia
Southern Oncology Clinical Research Unit (SOCRU)
Adelaide, South Australia, Australia
Safety and Tolerability of SUPLEXA in Subjects With Malignant Solid Tumour and Haematologic Malignancies.
Incidence of dose limiting toxicities measured by Incidence of adverse events and serious adverse events overall, by severity, by relationship to each study intervention, and those that led to discontinuation of study intervention. Note: due to patient availability, only solid tumour patients were enrolled
Time frame: 24 months
Solid Tumours Cohort: To Assess the Efficacy of SUPLEXA in Subjects With Malignant Solid Tumour as Assessed by the Investigator Based on Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 or by Changes in Tumour-derived Blood Biomarkers.
Objective response rate defined as the proportion of subjects with best overall response of either a complete response (CR) or partial response (PR) measured by Time to Progression (TTP). Complete Response (CR) is defined as disappearance of all target lesions; Partial Response (PR), is defined as at least 30% decrease in the sum of the longest diameter of target lesions.
Time frame: 24 months
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