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

Sponsor
Zelluna Immunotherapy AS
Study ID
NCT07613723
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

First listed
May 29, 2026
Start date
May 31, 2026
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2032

Study Design

Enrollment
9 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ZI-MA4-1 (TCR-NK cells)
    Participants 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).

Primary Outcome Measure

Safety and tolerability of ZI-MA4-1 [ Time Frame: From baseline through end of study visit (up to 5 years) ]

Central Contacts

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