drugset / Trial / NCT06980155
XP-005 Personalized Vaccine Alone or in Combination With Toripalimab for the Prevention of Relapse After Remission in Acute Myeloid Leukemia
Phase 0
Recruiting
60 enrolled
Shanghai Jiao Tong University School of Medicine
Shanghai Xinpu BioTechnology Company Limited · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The main objective of this study is to observe and evaluate the safety and tolerability of the XP-005 personalized tumor mRNA vaccine, either alone or in combination with toripalimab, for the treatment of acute myeloid leukemia patients who are in remission with minimal residual disease (MRD) positive but cannot undergo allogeneic hematopoietic stem cell transplantation.
Timeline
- Start
- 2025-05-30
- Primary completion
- 2027-01-30
- Completion
- 2028-08-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Toripalimab | Monoclonal antibody | 240 mg | — |
| Subject | XP-005 | Messenger RNA (mRNA) | 0.4 mg | — |
| Subject | XP-005 | Messenger RNA (mRNA) | 0.8 mg | — |
| Subject | XP-005 | Messenger RNA (mRNA) | 1 mg | — |