Phase I/II study of WT4869 for MDS
Phase 1
Terminated
- Conditions
- Myelodysplastic syndromes
- Registration Number
- JPRN-jRCT2080221337
- Lead Sponsor
- Sumitomo Dainippon Pharma Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- terminated
- Sex
- All
- Target Recruitment
- 26
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>safety<br>- Phase 1: to assess safety of WT4869 and to determine the recommended dose (RD) for the phase 2 part<br>- Phase 2: to assess safety and efficacy (exploratory) of WT4869 at the RD.<br>Safety: adverse events, dose-limiting toxity (phase 1), clinical laboratory test, vital sign, 12-led ECG<br>Efficacy (exploratory): hematologic improvement/treatment or cytogenetic response, time to AML, overall survival<br>Biomarker: DTH, CTL induction, anti-WT1 antibody, Treg ratio etc
- Secondary Outcome Measures
Name Time Method efficacy<br>hematologic response, hematologic improvement, cytogenetic effect, transition period to AML, and OS