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NCT05939037: MAGNAZ
Zanubrutinib Treatment in Patients With IgM Monoclonal Gammopathy and Antri-MAG Related Polyneuropathy
Phase 2 trial testing Zanubrutinib Oral Product in Monoclonal Gammopathy of Uncertain Significance in 35 participants. Currently enrolling.
1 October 2025
Quick facts
| Lead sponsor | UMC Utrecht |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 35 |
| Start date | 1 March 2024 |
| Primary completion | 1 October 2025 |
| Estimated completion | 1 October 2027 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- Zanubrutinib Oral Product — full drug profile →
Conditions studied
- Monoclonal Gammopathy of Uncertain Significance — all drugs for Monoclonal Gammopathy of Uncertain Significance →
Sponsor
UMC Utrecht — full company profile →
Who can join
18 and older, any sex, with Monoclonal Gammopathy of Uncertain Significance. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of this investigator-initiated phase II single-arm open-label clinical trial is to investigate neurological response rate, safety and tolerability of Zanubrutinib 320 mg daily in combination with Rituximab 375 mg/m2 (standard therapy) for the treatment of immunoglobulin M monoclonal gammopathy of unknown significance (IgM MGUS) related polyneuropathy with Myelin Associated Glycoprotein antibodies (anti-MAG). 42 adult patients will be included in two Dutch hospitals (University Medical Center Utrecht and Amsterdam University Medical Center). This trial consists of a 6-month treatment period, after which the hematological response will be evaluated. Adequately responding participants (at least partial response) will be treated for an additional 6 months, after which hematological response will be re-evaluated. Participants with at least a very good partial response will remain on treatment. Non-responding participants will be followed for clinical outcomes only. The total study period per participant will be 36 months.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05939037
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
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Trials testing the same drug.
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Other UMC Utrecht trials
Trials by the same sponsor.
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- NCT05375708 — Systemic Therapy in Combination with Stereotactic Radiotherapy in Patients with Metastatic Colorectal Cancer Up to 10 Me · Phase 2 · suspended
- NCT06898541 — Coronary Sinus Reducer in Coronary Microvascular Disease · NA · enrolling by invitation
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05939037 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by UMC Utrecht
- Last refreshed: 8 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05939037.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing