At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- ZI-MA4-1 (TCR-NK cells) (biological), Cyclophosphamide (drug), Fludarabine (drug)
- How long the study runs
- Study runs about 79 months (dates as stated)
- About the drug or intervention
- 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) · Cyclophosphamide — drug: Lymphodepleting chemotherapy · Fludarabine — drug: Lymphodepleting chemotherapy
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 75 Years
- Who
- All
- Number of participants
- 9
- Started
- 2026-05-11
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for ovarian cancer
- • Phase1 - 9 participants
- • 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
Who can take part?
- • Ages 18 Years to 75 Years
- • Diagnosed with ovarian cancer
Where?
- • London - The Royal Marsden NHS Foundation Trust
- • Manchester - The Christie NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 75 Years
- Who can join: All genders
- How fit you need to be: ECOG 0 or better
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ negative pregnancy test and agree to use an effective contraceptive method
What the study is looking for
- ✓HLA-A\*02:01 positive
- ✓Tumour(s) show expression of the MAGE-A4 protein above a defined threshold
- ✓No approved therapy with demonstrated clinical benefit is indicated or available to treat the patient, or the...
- ✓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...
Who cannot take part
- ✗Patients have received any prior cellular or gene therapy.
- ✗Receiving experimental investigational products within 4 weeks of lymphodepletion.
- ✗Residual toxicities ≥2 CTCAE grade due to prior therapy, that in the opinion of the investigator may interfere with...
- ✗Any other active cancer besides the tumour under study within 3 years prior to screening except for in situ...
- ✗Significant CNS disorders.
See the full criteria
Where Is This Study? (2 UK sites)
The Royal Marsden NHS Foundation Trust
London, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom
How to Get in Touch
Zelluna Immunotherapy
Sponsor contactCONTACT
