Study of SUPLEXA in Patients With Metastatic Solid Tumours and Haematologic Malignancies
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|ClinicalTrials.gov Identifier: NCT05237206|
Recruitment Status : Recruiting
First Posted : February 14, 2022
Last Update Posted : May 2, 2022
|Condition or disease||Intervention/treatment||Phase|
|Oncology||Biological: SUPLEXA||Phase 1|
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 Independent Data Monitoring Committee (IDMC) will provide oversight of the study and will monitor safety on a regular basis throughout the study to recommend on any modifications.
The study will be comprised of 3 periods. Screening, Treatment and Follow-up.
All eligible subjects are planned to receive a cumulative dose of SUPLEXA, with three doses each administered by infusion, at least 1 week apart. Subjects will be monitored closely at the clinic after each weekly infusion.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||non-comparative, open-label, basket-design study|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, First-in-Human, Open-label Single Agent Study of SUPLEXA Therapeutic Cells in Patients With Metastatic Solid Tumours and Haematologic Malignancies|
|Actual Study Start Date :||April 28, 2022|
|Estimated Primary Completion Date :||September 8, 2023|
|Estimated Study Completion Date :||May 1, 2024|
autologous cellular therapy comprised predominantly of NK, NKT, and T cells stored in cryogenic media
PBMC-derived autologous cellular therapy derived through an ex vivo activation procedure, resulting in a cell mixture comprised predominantly of NK, NKT, and T cells stored in cryogenic media.
- To assess safety and tolerability of SUPLEXA in subjects with malignant solid tumour and haematologic malignancies. [ Time Frame: 24 months ]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.
- 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. [ Time Frame: 24 months ]Objective response rate defined as the proportion of subjects with best overall response of either a complete response or partial response measured by Time to Progression (TTP)
- Haematologic malignancies cohort: To assess the efficacy of SUPLEXA in subjects with haematologic malignancies (multiple myeloma, lymphoma and chronic lymphocytic leukemia). [ Time Frame: 24 months ]Objective response rate as defined by standard of care.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05237206
|Contact: K Meademail@example.com|
|Principal Investigator:||Rohit Joshi, MD||Cancer Research South Australia (CRSA)|