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Ovarian CancerPhase 1NCT07613723

A Study to Test the Safety, Tolerability and Effect of ZI-MA4-1 for Patients With Locally Advanced or Metastatic Solid Malignancies

A Phase 1 study testing ZI-MA4-1 (TCR-NK cells), Cyclophosphamide and Fludarabine in people with Ovarian Cancer and Squamous Non-Small Cell Lung Cancer (NSCLC), run by Zelluna Immunotherapy AS at 2 sites in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study will recruit patients with the following cancer indications: ovarian cancer, squamous non-small cell lung cancer, synovial sarcoma and head and neck cancer, with inoperable locally advanced or metastatic solid tumours. Currently, these patients have a poor prognosis and a relatively short overall survival. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
ZI-MA4-1 (TCR-NK cells), Cyclophosphamide and Fludarabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
2 sitesUnited Kingdom
Study dates
11 May 2026to Dec 2032
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • HLA-A*02:01 positive
  • Tumour(s) show expression of the MAGE-A4 protein above a defined threshold
  • Histopathological or cytological diagnosis of inoperable Locally Advanced or Metastatic malignant disease: ovarian cancer, squamous non-small cell lung cancer (NSCLC), synovial sarcoma or head and neck cancer.
  • No approved therapy with demonstrated clinical benefit is indicated or available to treat the patient, or the patient is intolerant of or has refused standard of care therapy.
  • Documented imaging confirmed disease progression while on or within 6 months after the end of the most recent therapy.
  • Participant must have received ≥2 prior lines of cancer therapy except for patient with synovial sarcoma for whom ≥1 prior lines of cancer therapy.
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  • Measurable disease according to RECIST v1.1 criteria.
  • ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks, and an anticipated life expectancy of >3 months
  • Female participants are eligible to participate if they are not pregnant or breastfeeding. Woman of childbearing potential must have negative pregnancy test and agree to use an effective contraceptive method.
  • Other protocol defined inclusion criteria could apply.

Who cannot join

  • Patients have received any prior cellular or gene therapy.
  • Receiving experimental investigational products within 4 weeks of lymphodepletion.
  • Recent therapies (within up to 4 weeks prior to lymphodepletion) including biologic agents (such as monoclonal antibodies), anti-cancer immunotherapy (such as monoclonal antibodies against PD-1 receptor or ligand).
  • Residual toxicities ≥2 CTCAE grade due to prior therapy, that in the opinion of the investigator may interfere with study conduct.
  • Any other active malignancy besides the tumour under study within 3 years prior to screening except for in situ removal of basal cell carcinoma or adequately treated cervix carcinoma in-situ.
  • Active or documented history of autoimmune disease or any other diseases requiring immunosuppressive therapy or corticosteroid therapy. Physiological replacement, topical, and inhaled steroids are permitted.
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  • Significant CNS disorders.
  • Myocardial infarction, cardiac angioplasty or stenting, cardiac arrhythmia requiring medication, unstable angina, New York Heart Association Class II or greater congestive heart failure, cardiac atrial or ventricular lymphoma involvement, or other clinically significant cardiac disease within 6 months of enrolment.
  • Active fungal, bacterial viral, or other infection requiring intravenous antibiotic, antifungal, or antiviral medication within 7 days prior to lymphodepletion.
  • Received or planned to receive a live vaccine ≤6 weeks before the planned start date of lymphodepletion.
  • Severe or uncontrolled medical condition (e.g., severe chronic obstructive pulmonary disease, interstitial lung disease , severe Parkinson's disease, active inflammatory bowel disease) or psychiatric condition, which in the opinion of the investigator would interfere with study activities.
  • Active bleeding diatheses, including but not limited to therapeutic anticoagulation, and treatment with major surgery within 28 days before lymphodepletion (minor surgical procedures such as lymph node biopsy/excision or catheter placement are permitted).
  • Patients have significant immunosuppression
  • Known significant hepatic or biliary abnormalities. Active infection with hepatitis B, hepatitis C.
  • Any medical, psychological, or social condition, drug or alcohol abuse that would make it difficult for the patient to participate in the study and comply with the study procedures, restrictions, and requirements.
  • History of allergic reactions to compounds chemically or biologically similar to cyclophosphamide, fludarabine or other agents used in the study
  • QTc > 450 msec for male participants or > 470 msec for female participants
  • Medical conditions, such as anti-coagulation, which is not suitable for reversal which, at the opinion of the investigator, preclude or make the patient a poor candidate for biopsy.
  • Personal history of allergies or intolerance to local anaesthetic.
  • Recent treatment with immunosuppressive agents
  • Residual toxicities ≥2 Common Terminology Criteria for Adverse Events (CTCAE) grade due to prior therapy, that in the opinion of the investigator may interfere with study conduct Other protocol defined exclusion criteria could apply.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Zelluna Immunotherapy contact

+47 413 80 080

ctinfo@zelluna.com

United Kingdom2 sites, 2 recruiting

  • The Royal Marsden NHS Foundation Trust

    London

    Dr. Furness

    Recruiting

  • The Christie NHS Foundation Trust

    Manchester

    Prof. Thistlethwaite

    Recruiting

Other trials in United Kingdom

About this study

Official title: A Phase 1, Dose-Escalation, Open-Label Study, Evaluating the Safety and Tolerability of ZI-MA4-1, a TCR-NK Cell Therapy, in HLA-A*02:01 Positive Patients With Inoperable, Locally Advanced, or Metastatic MAGE-A4 Expressing Solid Malignancies

This study will recruit patients with the following cancer indications: ovarian cancer, squamous non-small cell lung cancer, synovial sarcoma and head and neck cancer, with inoperable locally advanced or metastatic solid tumours. Currently, these patients have a poor prognosis and a relatively short overall survival. There is a lack of meaningful, effective therapies available that improve the outcome for these patients. The treatment being investigated in this study is ZIMA4-1, an allogeneic cell therapy product. This is the first time ZI-MA4-1 will be administered to humans. The study is planned to consist of two parts (A and B). Part A includes up to four dose escalation cohorts and aims to identify the maximum tolerated dose of ZI-MA4-1 and give insight into the recommended Phase 2 dose (RP2D). Part B consists of an expansion cohort and is designed to further evaluate the RP2D identified in Part A across one or more indications. The study procedures and eligibility criteria will be the same for participants in Parts A and B, except for the dose level of ZI-MA4-1.

Being tested
ZI-MA4-1 (TCR-NK cells), Cyclophosphamide, Fludarabine
Medical subject headings
Ovarian Neoplasms, Sarcoma, Synovial, Head and Neck Neoplasms

What participants receive

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

  • ZI-MA4-1 (TCR-NK cells)Biological

    Allogeneic Natural Killer cells transduced with a T cell receptor targeting the tumour-specific melanoma-associated antigen 4 (MAGE-A4)

  • CyclophosphamideDrug

    Lymphodepleting chemotherapy

  • FludarabineDrug

    Lymphodepleting chemotherapy

Study groups in NCT07613723
Study groupRoleWhat they receive
ZI-MA4-1 (TCR-NK cells)ExperimentalParticipants receive ZI-MA4-1 administered via IV infusion 3 times per treatment cycle at their assigned dose. It is planned that all participants in the study will get a minimum of one treatment cycle and up to a maximum of two treatment cycles. Prior to a treatment cycle, a participant is given fludarabine and cyclophosphamide to temporarily reduce lymphocytes in the body (lymphodepletion).
Receives: Biological: ZI-MA4-1 (TCR-NK cells); Drug: Cyclophosphamide; Drug: Fludarabine

What is being measured

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

  1. Safety and tolerability of ZI-MA4-1

    Assessed using clinical assessments and adverse event reporting, including dose-limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), and treatment-related adverse events (TRAEs)

    Measured: From baseline through end of study visit (up to 5 years)

Secondary outcomes (7)

  1. MTD and RP2D of ZI-MA4-1

    Identification of maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of ZI-MA4-1 based on observed DLTs and predefined dose-escalation rules

    Measured: Through completion of study response follow-up (up to 2 years)

  2. Long term safety

    Evaluate ZI-MA4-1 for the occurrence of delayed adverse events (AEs)

    Measured: Through end of study visit (up to 5 years)

  3. Minimum biologically active dose (MBAD) of ZI-MA4-1

    Assessment of preliminary anti-tumour activity

    Measured: Through completion of study response follow-up (up to 2 years)

  4. Objective Response Rate (ORR)

    Assessed by RECIST 1.1

    Measured: Through completion of study response follow-up (up to 2 years)

  5. Best Overall Response (BOR)

    Assessed by RECIST 1.1

    Measured: Through completion of study response follow-up (up to 2 years)

  6. Disease Control Rate (DCR)

    Assessed by RECIST 1.1

    Measured: Through completion of study response follow-up (up to 2 years)

  7. Pharmacokinetics of ZI-MA4-1

    Evaluation of persistence of ZI-MA4-1 cells in the blood using vector copy number (VCN) analysis

    Measured: 3 years post-infusion of ZI-MA4-1

Timeline

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

  1. First posted29 May 2026
  2. Study start11 May 2026
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2032 (estimated)

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
Masking
None (open label)
Enrolment
9 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07613723
Sponsor's protocol ID
ZIMA-101
Other IDs
ISRCTN14753723
Status last verified
Sep 2026
First submitted
15 May 2026
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ZI-MA4-1 (TCR-NK cells), Cyclophosphamide and Fludarabine in people with Ovarian Cancer and Squamous Non-Small Cell Lung Cancer (NSCLC), run by Zelluna Immunotherapy AS at 2 sites in United Kingdom.

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 10 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Zelluna Immunotherapy (+47 413 80 080, ctinfo@zelluna.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability of ZI-MA4-1 (time frame: From baseline through end of study visit (up to 5 years)). 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 NCT07613723.

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 4 Sep 2026.

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Clinical Trial NCT07613723 | AzTrials