Actively Recruiting
Safety and Tolerability Study of ZI-MA4-1 TCR-NK Cell Therapy in HLA-A*02:01 Positive Patients With Inoperable, Locally Advanced, or Metastatic MAGE-A4 Expressing Solid Cancers
Led by Zelluna Immunotherapy AS · Updated on 2026-05-29
9
Participants Needed
2
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an investigational treatment called ZI-MA4-1, an allogeneic cell therapy, for patients with several types of advanced or metastatic solid cancers including ovarian cancer, squamous non-small cell lung cancer, synovial sarcoma, and head and neck cancer. These cancers currently have limited treatment options and a poor outlook. This Phase 1 study aims to assess the safety and tolerability of ZI-MA4-1 and to determine the best dose for future studies. Participants receive ZI-MA4-1 through intravenous infusion three times per treatment cycle, with each participant planned to receive at least one and up to two treatment cycles. Before each cycle, patients undergo lymphodepletion using chemotherapy drugs fludarabine and cyclophosphamide to prepare the body for the cell therapy. The study has two parts: Part A focuses on finding the maximum tolerated dose through dose escalation, and Part B expands evaluation of the recommended dose across different cancer types. During the study, participants will be monitored regularly for safety and treatment effects over up to five years. Researchers will assess responses using imaging and other tests to measure tumor changes, disease control, and how the therapy moves through the body. Participants must meet specific health and disease criteria to join, and the study includes careful follow-up to watch for any side effects or longer-term impacts of the treatment.
CONDITIONS
Brief Title
A Study to Test the Safety, Tolerability and Effect of ZI-MA4-1 for Patients With Locally Advanced or Metastatic Solid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- HLA-A*02:01 positive
- Tumor shows MAGE-A4 protein expression above a set level
- Diagnosed with inoperable locally advanced or metastatic ovarian cancer, squamous non-small cell lung cancer, synovial sarcoma, or head and neck cancer
- No approved effective therapy available or patient intolerant/refused standard treatment
- Documented disease progression during or within 6 months after last therapy
- At least 2 prior cancer treatments (at least 1 for synovial sarcoma)
- Measurable disease per RECIST v1.1 criteria
- ECOG performance status 0 or 1 with no recent decline and expected survival over 3 months
- Female participants not pregnant or breastfeeding; women of childbearing potential must have negative pregnancy test and use effective contraception
- Other protocol-defined inclusion criteria may apply
You will not qualify if you...
- Prior cellular or gene therapy
- Use of investigational products within 4 weeks before lymphodepletion
- Recent biologic therapies or anti-cancer immunotherapies within 4 weeks
- Residual toxicities grade 2 or higher from prior treatment interfering with study
- Other active cancers within 3 years except certain skin or cervix cancers
- Active or history of autoimmune or diseases requiring immunosuppressants or corticosteroids (except some steroid forms)
- Significant central nervous system disorders
- Recent serious heart conditions within 6 months
- Active infections requiring IV antibiotics/antifungals/antivirals within 7 days before lymphodepletion
- Live vaccine within 6 weeks before lymphodepletion
- Severe or uncontrolled medical or psychiatric conditions interfering with study
- Active bleeding disorders or recent major surgery within 28 days before lymphodepletion
- Significant immunosuppression
- Significant liver or biliary disease; active hepatitis B or C
- Conditions, substance abuse, or allergies making study participation difficult
- Allergies to cyclophosphamide, fludarabine, or similar agents
- QTc interval over 450 msec (men) or 470 msec (women)
- Medical conditions unsuitable for biopsy or with poor biopsy tolerance
- Personal allergy or intolerance to local anesthetics
- Recent immunosuppressive treatments
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 treatment cycles
Participants receive lymphodepleting chemotherapy followed by ZI-MA4-1 cell therapy administered via IV infusion in treatment cycles.
3 IV infusions per treatment cycle plus chemotherapy administration visits
Duration - Up to 5 years
Participants are monitored for safety, tolerability, and treatment response after completing treatment.
Regular visits for safety and response assessments during follow-up
Trial Site Locations
Total: 2 locations
1
The Royal Marsden NHS Foundation Trust
London, United Kingdom
Not Yet Recruiting
2
The Christie NHS Foundation Trust
Manchester, United Kingdom
Actively Recruiting
Research Team
Z
Zelluna Immunotherapy
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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