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

NCT05237206 | Completed Phase 1 Results DMC

• 1 other identifier: SUPLEXA-101
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Oncology

Keywords

autologous therapy; cellular therapy; T cell; NK-T cell; gamma delta T cell; CTL; PBMC-derived effector cells; NK cells

Outcome Measures

Primary Outcomes (1)

• 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

  24 months

Secondary Outcomes (1)

• 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.

  24 months

Study Arms (1)

SUPLEXA

EXPERIMENTAL

autologous cellular therapy comprised predominantly of NK, NK-T, and T cells stored in cryogenic media

Biological: SUPLEXA

Interventions

SUPLEXA BIOLOGICAL

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.

SUPLEXA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age
• Adult subjects at least 18 years of age at the time of signing the PICF.
• Type of Subject and Disease Characteristics Solid Tumours
• Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumour.
• Have 1 or more tumours measurable based on RECIST v1.1 as assessed by the local site Investigator. Radiographic scans should be obtained within 4 weeks of Screening. Lesions situated in a previously irradiated area are considered measurable if objective progression has been demonstrated following radiation to such lesions.
• Subjects who did not attain a durable response after receiving at least one standard/approved therapies which may include chemotherapy, targeted agents, radio-, immuno- conjugates, check point inhibitors or where there is no approved therapy. This includes subjects who attained a long-term stable disease (SD), or partial response (PR) are eligible. Long term SD subjects on a checkpoint inhibitor may continue checkpoint inhibitor (CPI) therapy.
• Haematologic malignancies
• Histologically or cytologically confirmed multiple myeloma, lymphoma, and chronic lymphocytic leukemia (collectively termed as haematologic malignancies for the purposes of this protocol) which has relapsed or is refractory advanced malignancy for which no curative standard therapy exists.

You may not qualify if:

• Medical Conditions
• Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Prior allogeneic transplant.
• Diagnosis of immunodeficiency or is receiving chronic and non-physiological, systemic steroid therapy or any other form of immunosuppressive therapy.
• Active uncontrolled bacterial, viral, or fungal infection requiring systemic therapy at screening or Day 1.
• History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator.
• Any unresolved Grade 2 or greater reversible toxicity from a previous anticancer therapy except for alopecia or Grade 2 neuropathy.
• Clinically significant cardiovascular disease, including any of the following:
• Stroke or myocardial infarction within 6 months prior to first dose in the study.
• Presence of unstable angina within 6 months prior to first dose in the study.
• Congestive heart failure of New York Heart Association Grade 2 or higher.
• History or presence of clinically significant ventricular arrhythmias, or conduction abnormality; presence of clinically significant atrial fibrillation and resting bradycardia.
• Corrected QT interval (QTcF) of \>450 msec (males) or \>470 msec (females) using Fridericia's correction formula.
• History of congenital long QT syndrome.
• Known history of testing positive for human immunodeficiency virus (HIV), and/or positive test for Hepatitis B virus surface antigen (HBsAg) and/or positive Hep C antibody result with detectable hepatitis C virus (HCV) ribonucleic acid (RNA) indicating acute or chronic infection.

Sponsors & Collaborators

• Alloplex Biotherapeutics Inc: lead

Study Sites (3)

Greenslopes Private Hospital/Gallipoli Medical Research Foundation

Brisbane, Queeensland, 4120, Australia

Location

Cancer Research Sa (Crsa)

Adelaide, South Australia, 5000, Australia

Location

Southern Oncology Clinical Research Unit (SOCRU)

Adelaide, South Australia, 5042, Australia

Location

Related Links

• Poster presentation at Society for Immunotherapy of Cancer by Alloplex Biotherapeutics, presenting results from this clinical trial.

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Dr. Sharron Gargosky, Chief Development Offier
• Organization: Alloplex Biotherapeutics

sgargosky@alloplexbio.com

+1 503-915-1400

Study Officials

• Rohit Joshi, MD

  Cancer Research South Australia (CRSA)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: non-comparative, open-label, basket-design study

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 14, 2022
• Study Start: April 28, 2022
• Primary Completion: July 23, 2024
• Study Completion: July 23, 2024
• Last Updated: September 18, 2025
• Results First Posted: September 18, 2025

Record last verified: 2025-08

Locations

AU (3)