Status:
COMPLETED
PBMC-based Leukocyte Immunotherapy
Lead Sponsor:
invIOs GmbH
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is an open-label, multicenter, dose-escalation Phase Ib trial of APN401, a suspension of viable Peripheral Blood Mononuclear Cells (PBMCs) from an individual patient that have been transfected wi...
Detailed Description
APN401 is a suspension of autologous Peripheral Blood Mononuclear Cells (PBMCs), transiently transfected with an siRNA to reduce Cbl-b protein levels. The administration of autologous Cbl-b silenced P...
Eligibility Criteria
Inclusion
- Patients of 18 years or older (all genders)
- Patients with histologically or cytologically confirmed locally advanced or metastatic solid tumors and who have failed standard treatment, have no standard treatment, or are not suitable for standard treatment at this stage as determined by the investigator
- Progressed on or refractory to at least two prior lines of systemic therapy
- At least one measurable lesion according to RECIST 1.1
- An Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
- Life expectancy of at least 3 months
- Adequate organ and bone marrow function, in the absence of growth factors, defined by specific laboratory parameters.
- Negative serology for human immunodeficiency virus, syphilis, hepatitis B and hepatitis C
- No prior chemotherapy, radiation therapy (except for palliative purpose), endocrine therapy, immunotherapy or investigational agent within 3 weeks (or five half-lives) prior to Day 0 (6 weeks for nitrosoureas and mitomycin C) before treatment
- Toxicities from previous anti-cancer therapies or surgical procedures to grade ≤1 that have not resolved (except alopecia)
- Previous exposure to a checkpoint inhibitor is allowed (except exposure of Cbl-b inhibition)
- Women of childbearing potential must have a negative pregnancy test, should not be breastfeeding, and must be willing to use highly effective methods of contraception for at least 1 month before, while participating in this study and until 1 month after the end of the treatment
- Patient voluntarily agrees to participate in this study and signs an Ethics Committee approved informed consent prior to performing any of the screening visit procedures, indicating that the patient understands the purpose and procedures required for the study
- Patient is not participating in any other interventional clinical study within the past 30 days
Exclusion
- Active untreated brain metastases
- Use of systemic corticosteroids (\> 10 mg prednisone or equivalent) within 15 days (except for prophylaxis for radiodiagnostic contrast reactions), or other immunosuppressive drugs within 30 days, prior to the first dose of APN401. Replacement therapy (e.g., physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
- Active, known, or suspected autoimmune disease except type I diabetes, vitiligo and thyroid disorders (thyroxine or insulin replacement therapy is allowed)
- Patients at high medical risk because of non-malignant systemic disease, active or unstable cardiac or cerebro-vascular disease, or active uncontrolled infection
- Any other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or APN401 administration, or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the patient unsuitable for the study
- Any vaccination prior and/or after 7 days while on APN401 treatment
Key Trial Info
Start Date :
August 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06172894
Start Date
August 22 2023
End Date
October 1 2024
Last Update
February 12 2025
Active Locations (4)
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1
Salzburg Cancer Research Institute (SCRI), Center for Clinical Cancer and Immunology Trials (CCCIT)
Salzburg, Salzburg, Austria, 5020
2
Medizinische Universität Innsbruck, Universitätsklinik für Innere Medizin V, Hämatologie und internistische Onkologie
Innsbruck, Tyrol, Austria, 6020
3
Ordensklinikum Linz, Barmherzige Schwestern, Abteilung für Hals-, Nasen-, Ohrenheilkunde
Linz, Upper Austria, Austria, 4010
4
Medizinische Universität Wien, Universitätsklinik für Transfusionsmedizin und Zelltherapie
Vienna, Vienna, Austria, 1090