Haplo-identical Natural Killer (NK) Cells to Prevent Post-Transplant Relapse in AML and MDS (NK-REALM)
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Myeloid Leukemia (AML)
- Myelodysplastic Syndromes (MDS)
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
The study is a Phase II, single arm, open label, multicenter trial evaluating the cumulative incidence of relapse when K-NK002 is used for relapse mitigation in patients with high-risk AML and MDS receiving an allogeneic haploidentical bone marrow graft. Part One (Safety run-in): An initial safety r...
The study is a Phase II, single arm, open label, multicenter trial evaluating the cumulative incidence of relapse when K-NK002 is used for relapse mitigation in patients with high-risk AML and MDS receiving an allogeneic haploidentical bone marrow graft. Part One (Safety run-in): An initial safety run-in to confirm the starting dose, and safety and tolerability of K-NK002; Dose cohort 1 will include 3 patients who will receive a dose of K-NK002 at 1 x 10E7 NK cells per kg. Dose cohort 2 will include 3 patients who will receive K-NK002 at 1 x 10E8 NK cells per kg. Part Two (Open Enrollment): Enrollment into the second part of the study (Open Enrollment) can begin following Part One, confirmation of dose and safety.
Tracking Information
- NCT #
- NCT04395092
- Collaborators
- Blood and Marrow Transplant Clinical Trials Network
- National Institutes of Health (NIH)
- National Heart, Lung, and Blood Institute (NHLBI)
- National Cancer Institute (NCI)
- Investigators
- Study Chair: Sumithira Vasu, MD Ohio State University Study Chair: Richard Champlin, MD M.D. Anderson Cancer Center
Get Well Soon