Trial Outcomes & Findings for Study of SUPLEXA in Patients With Metastatic Solid Tumours and Haematologic Malignancies (NCT NCT05237206)
NCT ID: NCT05237206
Last Updated: 2025-09-18
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
46 participants
Primary outcome timeframe
24 months
Results posted on
2025-09-18
Participant Flow
Participants were recruited from CANCER RESEARCH SA, Greenslopes Private Hospital/Gallipoli Medical Research Foundation and Southern Oncology Clinical Research Unit in Australia starting April 2022 to January 2024.
Participant milestones
| Measure |
SUPLEXA
Autologous, non-engineered cellular therapy comprised of lymphoid cells activated through a proprietary ex vivo procedure. A cryogenically stored product was prepared for all eligible participants to receive this adoptive immune cell therapy
|
|---|---|
|
Overall Study
STARTED
|
46
|
|
Overall Study
Allocated to Intervention
|
35
|
|
Overall Study
Analyzed
|
35
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
SUPLEXA
Autologous, non-engineered cellular therapy comprised of lymphoid cells activated through a proprietary ex vivo procedure. A cryogenically stored product was prepared for all eligible participants to receive this adoptive immune cell therapy
|
|---|---|
|
Overall Study
screen failure-did not receive treatment
|
8
|
|
Overall Study
did not receive treatment
|
3
|
Baseline Characteristics
Study of SUPLEXA in Patients With Metastatic Solid Tumours and Haematologic Malignancies
Baseline characteristics by cohort
| Measure |
SUPLEXA
n=35 Participants
Autologous, non-engineered cellular therapy comprised of lymphoid cells activated through a proprietary ex vivo procedure. A cryogenically stored product was prepared for all eligible participants to receive this adoptive immune cell therapy
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
35 Participants
n=5 Participants
|
|
Age of Participants
|
64 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Ethnicity of participants
Asian
|
4 Participants
n=5 Participants
|
|
Ethnicity of participants
White
|
31 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Intent to Treat Population (all participants allocated intervention) were assessed for adverse events.
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
Outcome measures
| Measure |
SUPLEXA
n=35 Participants
Autologous, non-engineered cellular therapy comprised of lymphoid cells activated through a proprietary ex vivo procedure. A cryogenically stored product was prepared for all eligible participants to receive this adoptive immune cell therapy.
|
|---|---|
|
Safety and Tolerability of SUPLEXA in Subjects With Malignant Solid Tumour and Haematologic Malignancies.
Number of Subjects reporting any Treatment Emergent Adverse Events
|
25 Participants
|
|
Safety and Tolerability of SUPLEXA in Subjects With Malignant Solid Tumour and Haematologic Malignancies.
Numer of Subjects reporting TEAE related to study intervention
|
3 Participants
|
|
Safety and Tolerability of SUPLEXA in Subjects With Malignant Solid Tumour and Haematologic Malignancies.
Number of Subjects with TEAE leading to discontinuation of study intervention
|
2 Participants
|
SECONDARY outcome
Timeframe: 24 monthsObjective 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.
Outcome measures
| Measure |
SUPLEXA
n=35 Participants
Autologous, non-engineered cellular therapy comprised of lymphoid cells activated through a proprietary ex vivo procedure. A cryogenically stored product was prepared for all eligible participants to receive this adoptive immune cell therapy.
|
|---|---|
|
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.
|
3 Number of participants: ORR
Interval 2.0 to 5.0
|
Adverse Events
SUPLEXA
Serious events: 6 serious events
Other events: 25 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
SUPLEXA
n=35 participants at risk
Autologous, non-engineered cellular therapy comprised of lymphoid cells activated through a proprietary ex vivo procedure. A cryogenically stored product was prepared for all eligible participants to receive this adoptive immune cell therapy.
|
|---|---|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.9%
1/35 • Number of events 1 • from enrollment through end of follow up, up to 24 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.5.0
|
|
Infections and infestations
Gasteroenteritis astroviral
|
2.9%
1/35 • Number of events 1 • from enrollment through end of follow up, up to 24 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.5.0
|
|
Gastrointestinal disorders
Ascites
|
2.9%
1/35 • Number of events 1 • from enrollment through end of follow up, up to 24 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.5.0
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.9%
1/35 • Number of events 1 • from enrollment through end of follow up, up to 24 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.5.0
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
2.9%
1/35 • Number of events 1 • from enrollment through end of follow up, up to 24 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.5.0
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
2.9%
1/35 • Number of events 1 • from enrollment through end of follow up, up to 24 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.5.0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.9%
1/35 • Number of events 1 • from enrollment through end of follow up, up to 24 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.5.0
|
Other adverse events
| Measure |
SUPLEXA
n=35 participants at risk
Autologous, non-engineered cellular therapy comprised of lymphoid cells activated through a proprietary ex vivo procedure. A cryogenically stored product was prepared for all eligible participants to receive this adoptive immune cell therapy.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
17.1%
6/35 • Number of events 6 • from enrollment through end of follow up, up to 24 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.5.0
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
8.6%
3/35 • Number of events 3 • from enrollment through end of follow up, up to 24 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.5.0
|
|
Gastrointestinal disorders
Nausea
|
14.3%
5/35 • Number of events 6 • from enrollment through end of follow up, up to 24 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.5.0
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
2/35 • Number of events 2 • from enrollment through end of follow up, up to 24 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.5.0
|
|
General disorders
Fatigue
|
22.9%
8/35 • Number of events 9 • from enrollment through end of follow up, up to 24 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.5.0
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.7%
2/35 • Number of events 2 • from enrollment through end of follow up, up to 24 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.5.0
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.7%
2/35 • Number of events 2 • from enrollment through end of follow up, up to 24 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.5.0
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.7%
2/35 • Number of events 4 • from enrollment through end of follow up, up to 24 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.5.0
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.7%
2/35 • Number of events 2 • from enrollment through end of follow up, up to 24 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.5.0
|
|
Nervous system disorders
Ageusia
|
5.7%
2/35 • Number of events 2 • from enrollment through end of follow up, up to 24 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.5.0
|
|
Nervous system disorders
Dizziness
|
5.7%
2/35 • Number of events 3 • from enrollment through end of follow up, up to 24 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.5.0
|
|
Nervous system disorders
Headache
|
8.6%
3/35 • Number of events 3 • from enrollment through end of follow up, up to 24 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.5.0
|
|
Psychiatric disorders
Insomnia
|
5.7%
2/35 • Number of events 3 • from enrollment through end of follow up, up to 24 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.5.0
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
5/35 • Number of events 7 • from enrollment through end of follow up, up to 24 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.5.0
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.6%
3/35 • Number of events 3 • from enrollment through end of follow up, up to 24 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.5.0
|
Additional Information
Dr. Sharron Gargosky, Chief Development Offier
Alloplex Biotherapeutics
Phone: +1 503-915-1400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place