NCT05201066

Roll-over Study for Patients Who Have Completed a Prior Novartis-sponsored Sabatolimab (MBG453) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Sabatolimab.

Active, enrolled Phase 2 Last updated 7 January 2026

What this trial tests

Phase 2 trial testing decitabine in Myelodysplastic Syndromes in 33 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

13 February 2023

Primary endpoint
14 February 2028

14 February 2028

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	33
Start date	13 February 2023
Primary completion	14 February 2028
Estimated completion	14 February 2028
Sites	24 locations across France, Italy, Japan, Greece, Malaysia, Germany, Canada, Switzerland

Drugs / interventions tested

• decitabine (decitabine) — full drug profile →
• spartalizumab
• sabatolimab
• azacitidine (azacitidine) — full drug profile →
• venetoclax (venetoclax) — full drug profile →
• INQOVI (oral decitabine)

Conditions studied

• Myelodysplastic Syndromes — all drugs for Myelodysplastic Syndromes →
• Leukemia, Myelomonocytic, Chronic — all drugs for Leukemia, Myelomonocytic, Chronic →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 12 to 99, any sex, with Myelodysplastic Syndromes or Leukemia, Myelomonocytic, Chronic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is intended to collect safety data from participants who completed the parent protocols but are still benefiting from study treatment. The study population consists of participants who tolerate study treatment of the parent studies. Collecting safety information from long-term exposure might offer the unique opportunity to detect rare Adverse Events.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Epigenetic regulation in the tumor microenvironment: molecular mechanisms and therapeutic targets.
   Yang J, Xu J, Wang W, Zhang B, et al · · 2023 · cited 251× · PMID 37217462 · DOI 10.1038/s41392-023-01480-x
2. LAG-3, TIM-3, and TIGIT: Distinct functions in immune regulation.
   Joller N, Anderson AC, Kuchroo VK. · · 2024 · cited 159× · PMID 38354701 · DOI 10.1016/j.immuni.2024.01.010
3. Recent advances in targeted therapies in acute myeloid leukemia.
   Bhansali RS, Pratz KW, Lai C. · · 2023 · cited 151× · PMID 36966300 · DOI 10.1186/s13045-023-01424-6
4. Immune evasion in cancer: mechanisms and cutting-edge therapeutic approaches.
   Tufail M, Jiang CH, Li N. · · 2025 · cited 82× · PMID 40739089 · DOI 10.1038/s41392-025-02280-1
5. Epi-immunotherapy for cancers: rationales of epi-drugs in combination with immunotherapy and advances in clinical trials.
   Xu Y, Li P, Liu Y, Xin D, et al · · 2022 · cited 29× · PMID 35642676 · DOI 10.1002/cac2.12313
6. The epigenetic hallmarks of immune cells in cancer.
   Ji Y, Xiao C, Fan T, Deng Z, et al · · 2025 · cited 28× · PMID 40038722 · DOI 10.1186/s12943-025-02255-4
7. Converting "cold" to "hot": epigenetics strategies to improve immune therapy effect by regulating tumor-associated immune suppressive cells.
   Tang Y, Cui G, Liu H, Han Y, et al · · 2024 · cited 28× · PMID 38715348 · DOI 10.1002/cac2.12546
8. Targeting natural killer cells: from basic biology to clinical application in hematologic malignancies.
   Shang J, Hu S, Wang X. · · 2024 · cited 13× · PMID 38396050 · DOI 10.1186/s40164-024-00481-y