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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05237206




Registration number
NCT05237206
Ethics application status
Date submitted
1/02/2022
Date registered
14/02/2022

Titles & IDs
Public title
Study of SUPLEXA in Patients With Metastatic Solid Tumours and Haematologic Malignancies
Scientific 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
Secondary ID [1] 0 0
SUPLEXA-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oncology 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - SUPLEXA

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


Treatment: Other: 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.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To assess safety and tolerability of SUPLEXA in subjects with malignant solid tumour and haematologic malignancies.
Timepoint [1] 0 0
24 months
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
Haematologic malignancies cohort: To assess the efficacy of SUPLEXA in subjects with haematologic malignancies (multiple myeloma, lymphoma and chronic lymphocytic leukemia).
Timepoint [2] 0 0
24 months

Eligibility
Key inclusion criteria
* Age

1. Adult subjects at least 18 years of age at the time of signing the PICF.

Type of Subject and Disease Characteristics Solid Tumours
2. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumour.
3. 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.
4. 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
5. 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Medical Conditions

1. Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
2. Prior allogeneic transplant.
3. Diagnosis of immunodeficiency or is receiving chronic and non-physiological, systemic steroid therapy or any other form of immunosuppressive therapy.
4. Active uncontrolled bacterial, viral, or fungal infection requiring systemic therapy at screening or Day 1.
5. 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.
6. Any unresolved Grade 2 or greater reversible toxicity from a previous anticancer therapy except for alopecia or Grade 2 neuropathy.
7. Clinically significant cardiovascular disease, including any of the following:

1. Stroke or myocardial infarction within 6 months prior to first dose in the study.
2. Presence of unstable angina within 6 months prior to first dose in the study.
3. Congestive heart failure of New York Heart Association Grade 2 or higher.
4. History or presence of clinically significant ventricular arrhythmias, or conduction abnormality; presence of clinically significant atrial fibrillation and resting bradycardia.
5. Corrected QT interval (QTcF) of >450 msec (males) or >470 msec (females) using Fridericia's correction formula.
6. History of congenital long QT syndrome.
8. 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.
9. 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.
10. At high risk of developing TLS per (Cairo, 2010)). Specifically:

1. Burkitt's lymphoma
2. ALL with LDH > 2xULN or WBC >100 x 109 per µL.
3. AML with WBC >100 x 109 per µL.
11. Any other condition that, in the opinion of the Investigator, would prohibit the subject from effectively participating in the study.

Diagnostic Assessments
12. 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)
13. 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.
14. 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.
15. 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.
16. 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
17. Participation in another clinical study of an investigational agent during the 2 weeks of this study's screening.

Other Exclusions
18. < 6 months life expectancy at the local site Investigator judgement.
19. 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/07/2024
Sample size
Target
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
QueeenslandSA
Recruitment hospital [1] 0 0
Greenslopes Private Hospital/Gallipoli Medical Research Foundation - Brisbane
Recruitment hospital [2] 0 0
Cancer Research Sa (Crsa) - Adelaide
Recruitment hospital [3] 0 0
Southern Oncology Clinical Research Unit (SOCRU) - Adelaide
Recruitment postcode(s) [1] 0 0
4120 - Brisbane
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
5042 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alloplex Biotherapeutics Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Rohit Joshi, MD
Address 0 0
Cancer Research South Australia (CRSA)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05237206