NCT05237206

Study of SUPLEXA in Patients With Metastatic Solid Tumours and Haematologic Malignancies

A Phase 1, First-in-Human, Open-label Single Agent Study of SUPLEXA Therapeutic Cells in Patients With Metastatic Solid Tumours and Haematologic Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Alloplex Biotherapeutics Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Oncology

Interventions

Type	Name	Description
BIOLOGICAL	SUPLEXA	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.

Timeline

• Start date: 2022-04-28
• Primary completion: 2024-07-23
• Completion: 2024-07-23
• First posted: 2022-02-14
• Last updated: 2025-09-18
• Results posted: 2025-09-18

Locations

3 sites across 1 country: Australia