OncologyPhase 1NCT05237206
Study of SUPLEXA in Patients With Metastatic Solid Tumours and Haematologic Malignancies
A Phase 1 study testing SUPLEXA in people with Oncology, run by Alloplex Biotherapeutics Inc at 3 sites in Australia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology
- What is being tested?
- SUPLEXA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 3 sitesAustralia
- Study dates
- 28 Apr 2022to 23 Jul 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- A serious non-malignant disease (e.g., psychiatric, substance abuse, uncontrolled intercurrent illness, etc.) that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.
- At high risk of developing TLS per (Cairo, 2010)). Specifically:
- Burkitt's lymphoma
- ALL with LDH > 2xULN or WBC >100 x 109 per µL.
- AML with WBC >100 x 109 per µL.
- Any other condition that, in the opinion of the Investigator, would prohibit the subject from effectively participating in the study.
- Diagnostic Assessments
- A performance status ≥2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale (solid tumours cohort) or Karnofsky performance scale of ≥60 (haematologic malignancies cohort)
- Does not demonstrate adequate organ function as defined as an excursion beyond the acceptable limits below. All screening laboratories should be performed at screening and on the day of first administration of study therapy.
- Prior radiotherapy within 2 weeks of start of study intervention. Subjects must have recovered from all radiation-related toxicities and not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
- Transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (CSF) (including granulocyte CSF [GCSF], granulocyte-macrophage CSF [GMCSF], or recombinant erythropoietin) within 4 weeks prior to baseline.
- Any vaccines (live, attenuated, inactivated or research vaccines) within 30 days of dosing with study intervention (refer to Section 6.8.1 for prohibited vaccines).
- Prior/Concurrent Clinical Study Experience
- Participation in another clinical study of an investigational agent during the 2 weeks of this study's screening.
- Other Exclusions
- < 6 months life expectancy at the local site Investigator judgement.
- Pregnant or breastfeeding female subjects within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study intervention.
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Cancer Research Sa (Crsa)
Adelaide, South Australia, 5000
Southern Oncology Clinical Research Unit (SOCRU)
Adelaide, South Australia, 5042
Greenslopes Private Hospital/Gallipoli Medical Research Foundation
Brisbane, Queeensland, 4120
About this study
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
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
Read the 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
- Being tested
- SUPLEXA
- Keywords
- autologous therapy, cellular therapy, T cell, NK-T cell, gamma delta T cell, CTL, PBMC-derived effector cells, NK cells
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUPLEXABiological
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.
| Study group | Role | What they receive |
|---|---|---|
| SUPLEXA | Experimental | autologous cellular therapy comprised predominantly of NK, NK-T, and T cells stored in cryogenic media Receives: Biological: SUPLEXA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start28 Apr 2022
- Primary completion23 Jul 2024
- Study completion23 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- non-comparative, open-label, basket-design study
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alloplex Biotherapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rohit Joshi, MD, Principal investigator, Cancer Research South Australia (CRSA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237206
- Sponsor's protocol ID
- SUPLEXA-101
- Status last verified
- Aug 2025
- First submitted
- 1 Feb 2022
- Last updated
- 18 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05237206
- Acronym / sponsor ID
- SUPLEXA-101
- Conditions
- Oncology
- Keywords
- autologous therapy, cellular therapy, T cell, NK-T cell, gamma delta T cell, CTL, PBMC-derived effector cells, NK cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Alloplex Biotherapeutics IncIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 23 Jul 2024 (actual)
- Study completion
- 23 Jul 2024 (actual)
- First posted
- 14 Feb 2022 (actual)
- Results
- Posted 18 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- non-comparative, open-label, basket-design study
| Arm | Type | Receives |
|---|---|---|
| SUPLEXA | Experimental | Biological: SUPLEXAautologous cellular therapy comprised predominantly of NK, NK-T, and T cells stored in cryogenic media |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age
- Type of Subject and Disease Characteristics Solid Tumours
- Haematologic malignancies
Key exclusion criteria (32 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SUPLEXAPBMC-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. | Biological | SUPLEXA |
Primary outcome
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. Note: due to patient availability, only solid tumour patients were enrolled
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Poster presentation at Society for Immunotherapy of Cancer by Alloplex Biotherapeutics, presenting results from this clinical trial.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rohit Joshi, MD principal investigator
Cancer Research South Australia (CRSA)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SUPLEXA in people with Oncology, run by Alloplex Biotherapeutics Inc at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of SUPLEXA in Subjects With Malignant Solid Tumour and Haematologic Malignancies. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.