Phase 1 study to test ZI‑MA4‑1 for patients with locally advanced or metastatic solid malignancies
Research type
Research Study
Full 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
IRAS ID
1013415
Contact name
Julia Ino
Contact email
Sponsor organisation
Zelluna Immunotherapy AS
ISRCTN Number
ISRCTN14753723
Clinicaltrials.gov Identifier
Research 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. There is a lack of meaningful effective therapies available that improve the outcome for these patients.
The treatment being investigated in this study is ZI-MA4-1, an allogeneic cell therapy product (made with cells from a health dinner). This is the first time ZI-MA4-1 will be administered to humans.
All participants will receive ZI-MA4-1 administered via IV infusion 3 times per 33-day 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 receiving ZI-MA4-1, participants will be given fludarabine and cyclophosphamide to temporarily reduce lymphocytes in the body (lymphodepletion).
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 Part A and B, except for the dose level of ZI-MA4-1.
In Part A, a maximum of 24 participants will be enrolled in up to four cohorts with up to six participants each. A maximum of 15 participants will be enrolled in Part B.
The total duration for participation is approximately 5 years & 2 months [including pre-screening (1 month), screening (23 days), treatment (33 days) and post treatment follow-up period of approximately 5 years)].
The study is sponsored by Zelluna Immunotherapy AS.
REC name
North East - York Research Ethics Committee
REC reference
26/NE/0005
Date of REC Opinion
20 Feb 2026
REC opinion
Further Information Favourable Opinion