A Phase I Single-arm Clinical Study of Donor NK Cells Infusion Combined with Low-dose Interleukin-2 in the Treatment of Acute Myeloid Leukemia Relapse After Allogeneic Hematopoietic Stem Cell Transplantation.
NCT06641648 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2024-10-15
Summary
This is a single-centre, single-arm, open-label, early clinical study to evaluate the safety, tolerability and preliminary efficacy of donor NK cells injection combined with low-dose interleukin-2 in the treatment of acute myeloid leukemia (AML) relapse after allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Conditions
- Acute Myeloid Leukemia (AML)
- Acute Myeloid Leukemia (AML) Relapse
- NK Cell
Interventions
- DRUG
-
NK cell
Drug: Donor NK cells injection is a non-genetically modified natural killer cells therapy derived from a healthy donor.
Sponsors & Collaborators
-
Peking University First Hospital
lead OTHER
Principal Investigators
-
Yujun Dong, Docter · Peking University First Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-01
- Primary Completion
- 2025-12-31
- Completion
- 2026-06-30
Countries
- China
Study Locations
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