A Phase 1, First-in-Human, Open-label Single Agent Study of SUPLEXA Therapeutic Cells in Patients With Metastatic Solid Tumours and Haematologic Malignancies
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Alloplex Biotherapeutics Inc
- Enrollment
- 46
- Locations
- 3
- Primary Endpoint
- Safety and Tolerability of SUPLEXA in Subjects With Malignant Solid Tumour and Haematologic Malignancies.
Overview
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
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
- •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.
Arms & Interventions
SUPLEXA
autologous cellular therapy comprised predominantly of NK, NK-T, and T cells stored in cryogenic media
Intervention: SUPLEXA (Biological)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)