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.

An open-label, multicenter, 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. - CMBG453B12206B

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2021240013

Enrollment

Registered

2024-06-27

Start date

2024-07-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia

Interventions

Sabatolimab (MBG453): Solution for intravenous infusion Azacitidine: Solution for subcutaneous injection or intravenous infusion Venetoclax: Tablet for oral administration Patients will take sabatolim

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Participant is currently enrolled in a Novartis-sponsored study with sabatolimab, is being treated with sabatolimab, and has fulfilled all requirements in the parent study. - Participant is currently benefiting from the treatment with sabatolimab as determined by guidelines of the parent protocol and investigator judgment. - Participant has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements. - Willingness and ability to comply with scheduled visits, treatment plan and any other study procedures. - Written informed consent obtained prior to enrolling in the roll-over study.

Exclusion criteria

Exclusion criteria: - Participants in cohorts or treatment groups not receiving sabatolimab in the parent protocol. - Participant has been permanently discontinued from sabatolimab treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent of any other reason. - Participant currently has unresolved toxicities for which sabatolimab dosing has been interrupted in the parent study (participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow sabatolimab dosing to resume). - Pregnant or nursing (lactating) women. Where pregnancy is defined as the state of a female after conception confirmed by a positive serum hCG laboratory test and until the termination of gestation. - Participant not willing to comply with the contraception requirements outlined in the exclusion criteria of the parent protocol. - Local access to commercially available sabatolimab for parent protocol indications.

Design outcomes

Primary

Measure	Time frame
Frequency and severity of AEs and SAEs	—

Countries

Argentina, Australia, Beugium, Brazil, Canada, China, Czech Republic, France, Germany, Greece, Italy, Japan, Malaysia, Mexico, Netherlands, Portugal, Russia, Saudi Arabia, South Korea, Spain, Switzerland, Turkey, United Kingdom, United States

Contacts

Public ContactKyosuke Yamauchi

Novartis Pharma. K.K.

rinshoshiken.toroku2@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026