Phase I/II Study of AdaptNK Cell Therapy in Patients with Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes
- Trial ID
- 2025-521962-83-00
- Sponsor
- Karolinska Institutet
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to evaluate the efficacy of natural killer (NK) cell therapy in patients diagnosed with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS). This intervention aims to address the high clinical risk associated with these hematologic malignancies by assessing the therapeutic potential of cellular immunotherapy to achieve disease control.
Participants
The sponsor did not provide information regarding the total number of participants. The study population consists of patients diagnosed with relapsed and/or refractory acute myeloid leukemia or myelodysplastic syndromes. The cohort includes both male and female individuals. The age range for the participants is categorized under specific clinical codes 3 and 4.
Plans and Procedures
This clinical trial is designed to evaluate the efficacy and safety of cell therapy in patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndromes. The research follows a specific methodology involving a sequence of study visits beginning with a screening visit to determine eligibility. Subsequent follow-up visits are scheduled to monitor clinical progress, concluding with an end-of-study visit. The total duration of participant involvement is determined by the clinical course and protocol requirements. Early termination from the study may occur based on predefined clinical conditions or safety criteria.
Treatment
Efficacy
Efficacy assessment in this clinical trial focuses on patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndromes. Specific parameters for evaluating treatment response or efficacy are not provided.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
Sweden | Not Yet Recruiting | 01 Jan 2026 | 26 |

