A Phase I Open-Label Dose Escalation Study of Intravenous INKmune In Patients With MDS or AML

Inclusion Criteria

• •1. Subject is ≥ 18 years old.
• •2. Subjects with:
• •1. MDS-EB-1/2, MDS-CMML 1-2 who have completed treatment with Azacytidine (AZA), and not achieved complete remission (CR) who are not thought to be fit for intensive chemotherapy.
• •2. Subjects with AML in complete remission (or complete remission with incomplete count recovery) unsuitable for intensive chemotherapy or allogeneic stem cell transplantation.
• •3. Subjects with relapsed MDS or AML post-allogeneic stem cell transplant, with slowly progressive disease unsuitable for intensive chemotherapy.
• •3. Subject has adequate organ and marrow function (as defined below):
• •1. Serum creatinine ≤ 1.5 X ULN, or measured creatinine clearance ≥ 60 ml/min/1.73m2.
• •2. Aspartate aminotransferase (AST) and ALT levels ≤ 3 X ULN.
• •3. Total bilirubin \< 1.5 X ULN, unless known diagnosis of Gilbert's syndrome.
• •4. Absolute neutrophil (ANC) ≥ 500/mm3; 0.5 x 109/L
• •5. Platelet count ≥ 50,000/mm3; 50 x 109/L
• •6. Haemoglobin ≥ 100mg/L (transfusion to obtain haemoglobin ≥ 100mg/L within 24 hours prior to dosing is allowed).
• •4. Subject must be at least 21 days from previous anticancer therapy (eg, chemotherapy, radiation therapy, immunotherapy and monoclonal antibodies, or investigational therapeutic agents) at the time of study screening and meet criteria in "3" above.
• •5. Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• •6. a. Sexually active female subjects of childbearing potential must agree to use a highly effective method of contraception for the duration of study therapy and for 3 months after the last dose of INKmune. Acceptable forms of contraception methods are as follows:
• •* Non-hormonal methods (i.e. intrauterine device, IUD)
• •* have vasectomised partner (the vasectomised partner must be the sole partner of the trial participant and have received medical assessment of its surgical success)
• •* True sexual abstinence Women of childbearing potential must discontinue any hormonal forms of birth control at least 4 weeks prior to first study dosing and commence using a highly effective, non- hormonal method as described above. Any pregnancy that occurs for study participants should be monitored for potential side effects.
• •b. Male subjects with partners who are of childbearing potential must agree a double barrier method of contraception i.e. condom with either cap or diaphragm for the duration of study therapy and for 3 months after the last dose of INKmune. Male subjects with partners who are pregnant must use a condom for the same duration to avoid INKmune exposure to developing foetus. Note: Subjects who are abstinent (defined as refraining from heterosexual intercourse during the entire period of risk associated with study treatments), must agree to remain abstinent for the study duration and for 3 months after the last study dose of INKmune. The reliability of sexual abstinence will be evaluated in relation to the preferred and usual lifestyle of the subject.
• •7. Subject, must be able to understand and voluntarily sign a written informed consent, and are willing and able to comply with the protocol requirements.
• •8. Subject must have a life expectancy greater than 3 months in the opinion of the PI.