Off-the-shelf Third Party Expanded NK Cells in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Allogeneic Stem Cell Transplant Recipient
- Blasts 10 Percent or More of Bone Marrow Nucleated Cells
- Myelodysplastic Syndrome
- Recurrent Acute Myeloid Leukemia
- Refractory Acute Myeloid Leukemia
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 1 years and 80 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVE: I. To determine the safety of adoptive NK cell therapy using membrane-bound interleukin-21 (mbIL21)-expanded, off-the-shelf, third-party donor-derived NK cells in patients with relapsed/refractory acute myeloid leukemia (AML). SECONDARY OBJECTIVES: I. Estimate the complete respons...
PRIMARY OBJECTIVE: I. To determine the safety of adoptive NK cell therapy using membrane-bound interleukin-21 (mbIL21)-expanded, off-the-shelf, third-party donor-derived NK cells in patients with relapsed/refractory acute myeloid leukemia (AML). SECONDARY OBJECTIVES: I. Estimate the complete response (CR, CR with incomplete hematologic recovery [CRi] & morphologic leukemia-free state [MLFS]). II. Estimate the median relapse free survival. III. Estimate the median time to neutrophil and platelet count recovery. IV. Estimate the median duration of remission. V. Estimate the incidence of infectious complications. VI. Estimate percentage of patients receiving this regimen who are rendered transplant-eligible. CORRELATIVE OBJECTIVES: I. Determine the persistence of ex-vivo expanded, off-the-shelf, third-party NK cells. II. Characterize in vivo expansion of third-party NK cells and if it differs based on the conditioning regimen as defined by NK chimerism assay. III. Determine the immunophenotype and function of expanded cells. IV. Chimerism analysis in patients who have had post-transplant relapses. OUTLINE: This is a dose-escalation study of membrane-bound interleukin-21-expanded haploidentical natural killer cells. INDUCTION: Patients are assigned to 1 of 2 arms. COHORT I: Patients who are < 60 years old, are able to tolerate intensive chemotherapy, and not insensitive to cytarabine receive fludarabine intravenously (IV) and cytarabine IV on days -6 to -2 in the absence of disease progression or unacceptable toxicity. COHORT II: Patients who are >= 60 years old, unable/unwilling to tolerate intensive chemotherapy, or disease insensitive to cytarabine (tp53, TET2 mutations) receive fludarabine IV on days -5 to -2 and decitabine IV on days -6 to -2 in the absence of disease progression or unacceptable toxicity. All patients receive membrane-bound interleukin-21-expanded haploidentical natural killer cells via infusion on days 0, 2, 4, 7, 9, and 11. After completion of study treatment, patients are followed up to day 56.
Tracking Information
- NCT #
- NCT04220684
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Sumithira Vasu, MBBS Ohio State University Comprehensive Cancer Center