Phase I/II study of WT4869 for MDS

A Phase I/II Study of WT4869 in Patients with Myelodysplastic Syndromes (MDS)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221337

Enrollment

Registered

2010-12-22

Start date

2011-07-12

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

Interventions

investigational material(s) Generic name etc : WT4869 INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Phase I: histologically and/or cytologically confirmed WHO-defined MDS - Phase II: histologically and/or cytologically confirmed MDS (WHO-defined) or refractory anemia with excess blasts in transformation (RAEB-t, FAB-defined) - 18 years or older - Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 - HLA-A*2402

Exclusion criteria

Exclusion criteria: - Patients with concomitant infectious disease that requiring systemic antibiotics, systemic antiviral drugs or other treatment - Pregnant or lactating females - Anti-HIV antibody, HBs antigen or anti-HCV antibody positivity in the last 3 months prior to enrollment

Design outcomes

Primary

Measure	Time frame
efficacy safety - Phase 1: to assess safety of WT4869 and to determine the recommended dose (RD) for the phase 2 part - Phase 2: to assess safety and efficacy (exploratory) of WT4869 at the RD. Safety: adverse events, dose-limiting toxity (phase 1), clinical laboratory test, vital sign, 12-led ECG Efficacy (exploratory): hematologic improvement/treatment or cytogenetic response, time to AML, overall survival Biomarker: DTH, CTL induction, anti-WT1 antibody, Treg ratio etc	—

Measure

Time frame

efficacy safety - Phase 1: to assess safety of WT4869 and to determine the recommended dose (RD) for the phase 2 part - Phase 2: to assess safety and efficacy (exploratory) of WT4869 at the RD. Safety: adverse events, dose-limiting toxity (phase 1), clinical laboratory test, vital sign, 12-led ECG Efficacy (exploratory): hematologic improvement/treatment or cytogenetic response, time to AML, overall survival Biomarker: DTH, CTL induction, anti-WT1 antibody, Treg ratio etc

—

Secondary

Measure	Time frame
efficacy hematologic response, hematologic improvement, cytogenetic effect, transition period to AML, and OS	—

Countries

Japan

Outcome results

None listed

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