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CancerPhase 1LAURELNCT05933070

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

A Phase 1 study testing INKmune in people with Cancer and MDS-EB, run by Inmune Bio, Inc. at 3 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, MDS-EB, Myelodysplastic Syndromes
What is being tested?
INKmune
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
3 sitesin 2 countries
Study dates
15 Jun 2020to 26 Apr 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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):
Show all 21Show fewer
  • 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:
  • 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.
  • 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.
  • Subject, must be able to understand and voluntarily sign a written informed consent, and are willing and able to comply with the protocol requirements.
  • Subject must have a life expectancy greater than 3 months in the opinion of the PI.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

United Kingdom2 sites

  • Sheffield Teaching Hospitals NHS FT - Royal Hallamshire Hospital

    Sheffield, Sheffield, S10 2RX

  • University Hospital Southampton NHS Foundation Trust

    Southampton, Hampshire, S016 6YD

Other trials in United Kingdom

Greece1 site

  • Attikon University General Hospital

    Athens, Attica, 124 62

Other trials in Greece

About this study

Official title: A Phase I Open-Label Dose Escalation Study Of Intravenous INKmune In Patients With Myelodysplastic Syndrome With Excess Blasts (MDS-EB-1/2 - MDS-CMML 1/2) Or Acute Myeloid Leukaemia (AML)

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.

Read the detailed description

INMB-INB16-002 is a Phase 1 open-label, dose escalation study of INKmune therapy in subjects with MDS with excess blasts without Auer rods (EB-1 or 2, or CMML 1 or 2) who have completed treatment with Azacytidine (AZA) and not achieved complete remission (CR) and who are not thought to be fit for intensive chemotherapy, or subjects with AML in complete remission (or complete remission with incomplete count recovery) unsuitable for intensive chemotherapy or allogeneic stem cell transplantation or subjects with relapsed MDS or AML post-allogeneic stem cell transplant with slowly progressive disease unsuitable for intensive chemotherapy.

Being tested
INKmune
Keywords
MDS, AML, NK Cell Based Therapy, Immune Based Therapy
Medical subject headings
Neoplasms, Myelodysplastic Syndromes, Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INKmuneBiological

    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.

Study groups in NCT05933070
Study groupRoleWhat they receive
Schedule of AssessmentsExperimentalINKmune 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.
Receives: Biological: INKmune

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2-3 years

  2. 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%.

    Measured: 2-3 years

Secondary outcomes (3)

  1. Secondary Objective 1

    To assess the overall response rate by measuring changes in percentage blasts in PB at days 29, 43, 73, 119 and BM at day 29.

    Measured: 1-2 years

  2. Secondary Objective 2

    To assess the overall response rate, partial response rate or complete response rate in subjects administered INKmune using the WHO criteria by measuring changes in vital signs, electrocardiogram (ECG), and safety laboratory parameters throughout the study.

    Measured: 3-4 years

  3. Secondary Objective 3

    To assess the progression-free survival (PFS) time defined as time to increase in transfusion dependence and or increase in percentage blasts in Peripheral Blood (PB) and/or Bone Marrow (BM).

    Measured: 2-3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2023
  2. Study start15 Jun 2020
  3. Primary completion28 Mar 2024
  4. Study completion26 Apr 2024

Why it stopped: Slow/low Enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05933070
Sponsor's protocol ID
INMB-INB16-002
Acronym
LAUREL
Status last verified
Jul 2024
First submitted
2 Jun 2023
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Arai S, Meagher R, Swearingen M, Myint H, Rich E, Martinson J, Klingemann H. Infusion of the allogeneic cell line NK-92 in patients with advanced renal cell cancer or melanoma: a phase I trial. Cytotherapy. 2008;10(6):625-32. doi: 10.1080/14653240802301872.

    PubMed 18836917

  • Bengala, C., V. Rasini, R. Sternieri, M. Dominici, A. Andreotti, R. Gelmini, L. Cafarelli, P. Bevini, A. Berti, and P. Conte. 2007. 'Phase I study of intraperitoneal MHC unrestricted adoptive cell therapy with TALL-104 cells in patients with peritoneal carcinosis', Journal of Clinical Oncology, 25: 3054-54.

  • Bryceson YT, March ME, Ljunggren HG, Long EO. Activation, coactivation, and costimulation of resting human natural killer cells. Immunol Rev. 2006 Dec;214:73-91. doi: 10.1111/j.1600-065X.2006.00457.x.

    PubMed 17100877

  • Carlsten M, Baumann BC, Simonsson M, Jadersten M, Forsblom AM, Hammarstedt C, Bryceson YT, Ljunggren HG, Hellstrom-Lindberg E, Malmberg KJ. Reduced DNAM-1 expression on bone marrow NK cells associated with impaired killing of CD34+ blasts in myelodysplastic syndrome. Leukemia. 2010 Sep;24(9):1607-16. doi: 10.1038/leu.2010.149. Epub 2010 Jul 8.

    PubMed 20613786

  • Carlsten M, Norell H, Bryceson YT, Poschke I, Schedvins K, Ljunggren HG, Kiessling R, Malmberg KJ. Primary human tumor cells expressing CD155 impair tumor targeting by down-regulating DNAM-1 on NK cells. J Immunol. 2009 Oct 15;183(8):4921-30. doi: 10.4049/jimmunol.0901226.

    PubMed 19801517

  • Cesano A, Santoli D. Two unique human leukemic T-cell lines endowed with a stable cytotoxic function and a different spectrum of target reactivity analysis and modulation of their lytic mechanisms. In Vitro Cell Dev Biol. 1992 Sep-Oct;28A(9-10):648-56. doi: 10.1007/BF02631041.

    PubMed 1429367

  • Chandhok NS, Boddu PC, Gore SD, Prebet T. What are the most promising new agents in myelodysplastic syndromes? Curr Opin Hematol. 2019 Mar;26(2):77-87. doi: 10.1097/MOH.0000000000000483.

    PubMed 30632987

  • Epling-Burnette PK, Bai F, Painter JS, Rollison DE, Salih HR, Krusch M, Zou J, Ku E, Zhong B, Boulware D, Moscinski L, Wei S, Djeu JY, List AF. Reduced natural killer (NK) function associated with high-risk myelodysplastic syndrome (MDS) and reduced expression of activating NK receptors. Blood. 2007 Jun 1;109(11):4816-24. doi: 10.1182/blood-2006-07-035519. Epub 2007 Mar 6.

    PubMed 17341666

  • Fehniger TA, Miller JS, Stuart RK, Cooley S, Salhotra A, Curtsinger J, Westervelt P, DiPersio JF, Hillman TM, Silver N, Szarek M, Gorelik L, Lowdell MW, Rowinsky E. A Phase 1 Trial of CNDO-109-Activated Natural Killer Cells in Patients with High-Risk Acute Myeloid Leukemia. Biol Blood Marrow Transplant. 2018 Aug;24(8):1581-1589. doi: 10.1016/j.bbmt.2018.03.019. Epub 2018 Mar 27.

    PubMed 29597002

  • Fozza C. The burden of autoimmunity in myelodysplastic syndromes. Hematol Oncol. 2018 Feb;36(1):15-23. doi: 10.1002/hon.2423. Epub 2017 Apr 27.

    PubMed 28449370

  • Gong JH, Maki G, Klingemann HG. Characterization of a human cell line (NK-92) with phenotypical and functional characteristics of activated natural killer cells. Leukemia. 1994 Apr;8(4):652-8.

    PubMed 8152260

  • Hou HA, Tsai XC, Lin CC, Chou WC, Kuo YY, Liu CY, Tseng MH, Peng YL, Liu MC, Liu CW, Liao XW, Lin LI, Yao M, Tang JL, Tien HF. Incorporation of mutations in five genes in the revised International Prognostic Scoring System can improve risk stratification in the patients with myelodysplastic syndrome. Blood Cancer J. 2018 Apr 4;8(4):39. doi: 10.1038/s41408-018-0074-7.

    PubMed 29618722

  • Kiladjian JJ, Bourgeois E, Lobe I, Braun T, Visentin G, Bourhis JH, Fenaux P, Chouaib S, Caignard A. Cytolytic function and survival of natural killer cells are severely altered in myelodysplastic syndromes. Leukemia. 2006 Mar;20(3):463-70. doi: 10.1038/sj.leu.2404080.

    PubMed 16408099

  • Kottaridis PD, North J, Tsirogianni M, Marden C, Samuel ER, Jide-Banwo S, Grace S, Lowdell MW. Two-Stage Priming of Allogeneic Natural Killer Cells for the Treatment of Patients with Acute Myeloid Leukemia: A Phase I Trial. PLoS One. 2015 Jun 10;10(6):e0123416. doi: 10.1371/journal.pone.0123416. eCollection 2015.

    PubMed 26062124

  • Lanier LL. Up on the tightrope: natural killer cell activation and inhibition. Nat Immunol. 2008 May;9(5):495-502. doi: 10.1038/ni1581.

    PubMed 18425106

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing INKmune in people with Cancer and MDS-EB, run by Inmune Bio, Inc. at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Slow/low Enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Objective 1 (time frame: 2-3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05933070, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.

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