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

NCT05933070 | Terminated Phase 1

• 1 other identifier: INMB-INB16-002
• Study Type: interventional
• Target: 2
• Locations: 2 countries
• Sites: 3

Brief Summary

INMB-INB16-002 is a Phase I open-label, dose escalation study of INKmune therapy in subjects with myelodysplastic syndrome (MDS) with excess blasts without Auer rods (EB-1 or 2, or CMML 1 or 2) or subjects with acute myeloid leukaemia (AML) in complete remission.

Conditions

Cancer; MDS-EB; Myelodysplastic Syndromes; Acute Myeloid Leukemia; AML

Keywords

MDS; AML; NK Cell Based Therapy; Immune Based Therapy

Outcome Measures

Primary Outcomes (2)

• Primary Objective 1

  Identify the incidence and seriousness of AEs and their relationship (causality) to INKmune as graded by NCI CTCAE criteria v.5.0.

  2-3 years

• Primary Objective 2

  Identify a RP2D of INKmune. The RP2D is defined as the maximum tolerated dose (MTD) of the agent which will be defined as the dose at which the complication rate is less than 33%.

  2-3 years

Secondary Outcomes (3)

• Secondary Objective 1

  1-2 years

• Secondary Objective 2

  3-4 years

• Secondary Objective 3

  2-3 years

Other Outcomes (1)

• Exploratory Objective 1

  2-3 years

Study Arms (1)

Schedule of Assessments

EXPERIMENTAL

INKmune therapy will be administered by a slow intravenous injection via conventional blood giving set. Patients will receive 3 weekly IV doses of INKmune on Day 1, 8, and 15. * In Cohort 1, the initial planned dose is 1 x 10\^8 INKmune; * In Cohort 2, the weekly dose will increase to 3 x 10\^8 INKmune; * In Cohort 3, the weekly dose will increase to 5 x 10\^8 INKmune.

Biological: INKmune

Interventions

INKmune BIOLOGICAL

INKmune is a patented biologic delivery system and method for cancer treatment using in vivo priming and activation of natural killer (NK) cells in order to achieve tumor cell lysis. INKmune is a suspension of INB16 cells which have been rendered replication incompetent. INKumne is a replication-incompetent tumor cell line that does not require donor matching.

Schedule of Assessments

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is ≥ 18 years old.
• Subjects with:
• 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.
• Subjects with AML in complete remission (or complete remission with incomplete count recovery) unsuitable for intensive chemotherapy or allogeneic stem cell transplantation.
• Subjects with relapsed MDS or AML post-allogeneic stem cell transplant, with slowly progressive disease unsuitable for intensive chemotherapy.
• Subject has adequate organ and marrow function (as defined below):
• Serum creatinine ≤ 1.5 X ULN, or measured creatinine clearance ≥ 60 ml/min/1.73m2.
• Aspartate aminotransferase (AST) and ALT levels ≤ 3 X ULN.
• Total bilirubin \< 1.5 X ULN, unless known diagnosis of Gilbert's syndrome.
• Absolute neutrophil (ANC) ≥ 500/mm3; 0.5 x 109/L
• Platelet count ≥ 50,000/mm3; 50 x 109/L
• Haemoglobin ≥ 100mg/L (transfusion to obtain haemoglobin ≥ 100mg/L within 24 hours prior to dosing is allowed).
• 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.
• Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• 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:

You may not qualify if:

• Subject diagnosed with any other sub-classification of MDS.
• Subject is currently receiving cancer-specific treatment with the exceptions of supportive treatments such as bisphosphonate or steroid treatments for symptomatic control.
• Subject has had prior NK cell targeting therapy.
• Subject has a current requirement for steroids \> 10 mg daily; prednisolone or equivalent.
• Subject has impaired cardiac function or clinically significant cardiac disease including the following:
• New York Heart Association grade III or IV congestive heart failure.
• Myocardial infarction within the last 6 months prior to dosing with INKmune
• Impaired left ventricular ejection fraction (LVEF \< 40%) as assessed according to institutional standards.
• Subject has shown lack of recovery of prior AEs to Grade ≤1 severity (NCI CTCAE v5.0) (except alopecia) due to therapy administered prior to the initiation of study drug dosing. Stable persistent grade 2 peripheral neuropathy may be allowed as determined on a case-by-case basis at the discretion of the PI and Medical Monitor.
• Subject has known allergy to any of the formulation components of INKmune.
• Subjects has active, severe infection requiring systemic treatment. Subjects may become eligible once infection has resolved and they are at least seven days from completion of antibiotics.
• Subject concomitant use of complementary or alternative medication or other agents (investigational therapeutic agents) will not be allowed without approval of a PI or sub- investigator (SI). Every effort will be made to maximize subject safety and minimize changes in chronic medications.
• Subject is pregnant or is currently breastfeeding.
• Subject has uncontrolled seizures as determined by the PI.
• Subject has any other condition or finding that in the opinion of the PI or Sponsor Medical Monitor may render the subject at excessive risk for treatment complications or may not be able provide evaluable outcome information.

Sponsors & Collaborators

• Inmune Bio, Inc.: lead

Study Sites (3)

Attikon University General Hospital

Athens, Attica, 124 62, Greece

Location

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, S016 6YD, United Kingdom

Location

Sheffield Teaching Hospitals NHS FT - Royal Hallamshire Hospital

Sheffield, Sheffield, S10 2RX, United Kingdom

Location

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MeSH Terms

Conditions

Neoplasms; Myelodysplastic Syndromes; Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type

Study Officials

• Nicole Kay-Mindick

  INmune Bio

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Open-Label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will receive 3 weekly IV doses of INKmune on Day 1, 8, and 15 in addition to supportive care. Three cohorts, comprised of at least 3 participants, are planned. Each participant will be screened up to 28 days prior to treatment. After participants have received all doses, they will be reviewed at Day 29 and Day 43 and then followed up with monthly clinic appointments for the following 3 months (Days 73 and 119) for clinical assessment and blood tests. Once Day 119 visit is completed this classifies end of study for the participant. The trial will end after data collection has been completed for each trial participant.

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: July 6, 2023
• Study Start: June 15, 2020
• Primary Completion: March 28, 2024
• Study Completion: April 26, 2024
• Last Updated: March 30, 2026

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1); GB (2)