None listed
Conditions
Brief summary
This study is aiming to evaluate safety, tolerability and immune cell profile of one dose of Activated Immune Cells with Anti-Cancer Phenotype in healthy volunteers Who is it for? You may be eligible to join this study if you are aged 18 to 70 years, are in good general health medically without a clinically significant medical history. This study is only for healthy volunteers. People who have been diagnosed with cancer will not be eligible for this study. Study details All participants will go through screening, peripheral blood mononuclear cell (PBMC) harvest, treatment and follow-up over a 20 week-period. Participants will receive a single intravenous infusion of Activated Immune Cells with Anti-Cancer Phenotype prepared using their own blood during the PBMC harvest period. Participants will then undergo physical examinations, clinical monitoring and laboratory assessments at regular follow-up visits to determine safety, tolerability and immune cell profile of the treatment. This research aims to advance the clinical development of Activated Immune cells with Anti-cancer phenotype, an autologous immune cell therapy initially focused on treating non-small cell lung cancer, with the hope of expanding its application to other cancers and immune-related conditions, ultimately contributing to improved treatment options and health outcomes for patients with limited current therapies.
Interventions
This study will assess the safety, tolerability and immune cell profile of one dose of Activated Immune Cells with Anti-Cancer Phenotype in healthy volunteers.
Each healthy participant will receive a single intravenous infusion of Activated Immune Cells with Anti-Cancer Phenotype. Dose is dependent on harvested immune cells from participants and the dose administered will not be lower than 0.5 x 10^8 and not exceed 2 x 10^8.
The total maximum duration of the study will be 136 days (approximat
This study will assess the safety, tolerability and immune cell profile of one dose of Activated Immune Cells with Anti-Cancer Phenotype in healthy volunteers. Each healthy participant will receive a single intravenous infusion of Activated Immune Cells with Anti-Cancer Phenotype. Dose is dependent on harvested immune cells from participants and the dose administered will not be lower than 0.5 x 10^8 and not exceed 2 x 10^8. The total maximum duration of the study will be 136 days (approximately 20 weeks). This includes a screening period of up to 29 days (Day -46 to Day -18), a 91-day treatment and follow-up period (Day -1 to Day 90), the dose will be given on Day 1 and the duration of the infusion will take approximately 30minutes. PBMC harvest (Day -17) The participant will report to the clinic 17 days prior to dosing for the collection of a blood sample (approximately 150ml) for the purpose of isolating PBMCs and preparing the Activated Immune Cells with Anti-Cancer Phenotype. They will be required to attend the clinic for approximately 1.5 to 2 hours to ensure that a sufficient blood volume has been collected, relevant tests completed and that they are able to leave safely. Adherence will be completed via a schedule of assessments: Screening, PBMC harvest, Treatment period, Follow up (Self-monitoring Day 1, 2, 3, 4 & 14, Clinical outpatient visit - day 35, Phone call Day 63, End of Study Visit/Early Termination Visit - Day 90. Self-monitoring will occur at the participants' home. Follow-ups and monitoring will be completed by clinical facility staff and includes, blood tests, vitals, ECG, Pharmacodynamics analysis, concomitant medication, physical examination.
Sponsors
Aeterna Health Services PTY LTD
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects; 2. Adult males and females, 18 to 70 years of age (inclusive) at screening; 3. Body mass index greater than or equal to 18.0 and less than or equal to 30.0 kg/m2, with a body weight greater than or equal to 50 kg at screening; 4. Be nonsmokers (including tobacco, e-cigarettes and marijuana) for at least 1 month prior to first study treatment administration; 5. Medically healthy without clinically significant abnormalities at screening and pre dose on Day 1, including: a. Physical examination without any clinically relevant findings; b. Systolic blood pressure in the range of 90 to 160 mmHg and diastolic blood pressure in the range of 50 to 95 mmHg after 5 minutes in supine position; c. Heart rate ( HR) in the range of 50 to 100 bpm after 5 minutes rest in supine position; d. Body temperature, between 35.0 °C and 37.5 °C; e. No clinically significant findings in serum chemistry, haematology, coagulation and urinalysis tests as judged by the investigator; 6 . Conventional 12-lead electrocardiogram (ECG) recording in triplicate (the mean of triplicate measurements will be used to determine eligibility at screening and pre dose on Day 1) consistent with normal cardiac conduction and function, including: a. Normal sinus rhythm with HR between 50 and 100 bpm, inclusive; b. QT interval corrected using the Fridericia method ( QTcF) between 350 to 450 msec for male subjects and 350 to 470 msec for female subjects, inclusive; c. QRS duration of less than 120 msec; d. PR interval of less than or equal to 210 msec; e. Electrocardiogram morphology consistent with healthy cardiac ventricular conduction and normal rhythm, and with measurement of the QT interval; f. No family history of short or long QT syndrome; g. No history of risk factors for torsade de pointes or the diagnosis; 7 . Female participants must: a. Be of nonchildbearing potential ie, surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before screening) or postmenopausal ( where postmenopausal is defined as no menses for 12 months without an alternative medical cause), or b. If of childbearing potential, must have a negative pregnancy test at screening (blood test) and before the first study treatment administration (Day - 1 urine test). They must agree not to attempt to become pregnant, must not donate ova, and must use a highly effective contraceptive method from signing the consent form until at least 30 days after the last dose of study treatment. 8 . Male participants, if not surgically sterilized, must be willing not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must bewilling to use a condom in addition to having the female partner use a highly effective contraceptive method from signing the consent form until at least 90 days after the last dose of study treatment; 9. Have suitable venous access for peripheral blood mononuclear cell (PBMC) collection and blood sampling; 10. Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
Exclusion criteria
1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or surgery within the past 3 months determined by the PI to be clinically relevant; 2. Current infection that requires antibiotic, antifungal, antiparasitic or antiviral medications; 3. Any history of malignant disease in the last 10 years (excludes surgically resected skin squamous cell or basal cell carcinoma); 4. Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia; 5. Use of or plans to use systemic immunosuppressive (eg, corticosteroids, methotrexate, azathioprine, cyclosporine) or immunomodulating medications (eg, interferon) during the study or within 4 months prior to the first study treatment administration; 6. Liver function test results (ie, aspartate aminotransferase [AST], alanine aminotransferase [ALT], and gamma glutamyl transferase [GGT]) and total bilirubin must not be elevated more than 1.2-fold above the upper limit of normal (ULN); 7. Positive test results for active human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, human T-lymphotropic virus (HTLV)- 1/2 antibodies or syphilis; 8. Presence or having sequelae of gastrointestinal, liver, kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs; 9. Estimated creatinine clearance (CrCl) < 40 mL/min using the Cockcroft-Gault formula or serum creatinine more than 1.5-fold above the ULN; 10. History of substance abuse or alcohol abuse within 12 months prior to first study treatment administration; 11. Positive drug or alcohol test results; 12. Use of any prescription or over-the-counter medication (including herbal products, diet aids, and hormone supplements) within 10 days or 5 half-lives of the medication (whichever is longer) prior to the first study treatment administration, except occasional use of paracetamol; 13. Demonstrated clinically significant (required intervention, eg, emergency room visit, epinephrine administration) allergic reactions (eg, food, drug, or atopic reactions, asthmatic episodes) which, in the opinion of the investigator, would interfere with the volunteer’s ability to participate in the trial; 14. Known hypersensitivity to any of the study treatment ingredients; 15. Use of any live vaccinations within 30 days prior to the first study treatment administration except for the influenza vaccine; 16. For women of childbearing potential, a positive serum pregnancy test at screening or a positive urine pregnancy test with confirmatory serum pregnancy test on Day - 1; 17. Donation of blood or plasma within 30 days prior to first study treatment administration, or loss of whole blood of more than 500 mL within 30 days prior to randomization, or receipt of a blood transfusion within 1 year of first study treatment administration; 18. Participation in another investigational clinical trial within 60 days prior to the first study treatment administration; 19. Any other condition or prior therapy that in the opinion of the PI would make the volunteer unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements; 20. Is an employee of an investigator or sponsor or an immediate relative of an investigator
Outcome results
None listed