Clinical trial · Interventional
B7.1/IL-2 Leukaemia Cell Vaccine for Non-Transplant AML RFUSIN2-AML2 (NTX)
A Phase I Study of B7.1 (CD80)/IL-2 Immune Gene Therapy for High Risk MDS RAEB-2 and Acute Myeloid Leukaemia Patients Unsuitable for Allogeneic Haematological Stem Cell Transplant
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study will be an open label, single arm, phase I study intended to identify the safety and tolerability of "AML Cell Vaccine" given to eligible MDS RAEB-2 and AML patients who have achieved a best response of complete remission or partial remission following their first or second course of standard induction chemotherapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Myeloid, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AML Cell Vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AML Cell Vaccine
- interventionNames
- Biological: AML Cell Vaccine
Primary outcomes (2)
- measure
- Vaccine-related toxicity based on the NCI criteria V4.0
- timeFrame
- 52 weeks
- measure
- Frequency, severity of adverse events to the AML cell vaccine
- timeFrame
- 52 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Diagnosis of MDS RAEB-2 or primary (de novo) or secondary AML defined according to the WHO classification either as a new diagnosis or as a relapse. * Patients for whom the optimal therapy in CR1 would be to undergo allogeneic bone marrow transplantation, but for whom this procedure is either not recommended (e.g. due to comorbidities) or not available (e.g. lack of a suitable donor). Key Exclusion Criteria: * Patients with MDS RAEB-2 or AML and favourable prognostic profile (good risk cytogenetics: t(15;17)(q22;q12\~21), inv16(p13q22)/t(16;16)(p13;q22), t(8;21)(q22;q22) or cytogenetically normal AML with NPM1 mutation and absence of Flt-3 ITD). * Patients unsuitable for standard induction chemotherapy. * Patients who have previously undergone or will be able to undergo allogeneic transplantation. * Patients who have had previous or current treatment with any form of investigational immunotherapy.
References
Publications (0)
Data not yet available