A Phase 1 Trial of CIML NK Cell Infusion for Myeloid Disease Relapse After Hematopoietic Cell Transplantation
NCT04024761 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-04-03
Summary
This research study is studying cytokine induced memory-like natural killer (CIML NK) cells combined with IL-2 in adult patients (18 years of age or older) with Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS) and Myeloproliferative Neoplasms (MPN) who relapse after haploidentical hematopoietic cell transplantation (haplo-HCT) or HLA matched stem cells. This study will also study CIML NK cell infusion combined with IL-2 in pediatric patients (12 years of age or older) with AML, MDS, JMML who relapse after stem cell transplantation using HLA-matched related donor or related donor haploidentical stem cells.
Conditions
- Acute Myeloid Leukemia
- Myelodysplastic Syndromes
- Myeloproliferative Neoplasm
- Juvenile Myelomonocytic Leukemia
Interventions
- BIOLOGICAL
-
CIML NK
CIML NK cells have enhanced ability to recognize and kill leukemia targets
- DRUG
-
Fludarabine is a chemotherapy agent
- DRUG
-
Cyclophosphamide (CP), also known as cytophosphane among other names, is a chemotherapy agent
Sponsors & Collaborators
-
The Leukemia and Lymphoma Society
collaborator OTHER - lead OTHER
Principal Investigators
-
Susanne Baumeister, MD · Dana-Farber Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-08-31
- Primary Completion
- 2026-12-01
- Completion
- 2026-12-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Phase I Study of Adoptive Immunotherapy With Enriched and Expanded Autologous Natural Killer (NK) Cells for Patients With Ph+ Acute Lymphoblastic Leukemia (ALL)
NCT02185781 ·Status: COMPLETED ·Phase: PHASE1
-
Immunotherapy for Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Blast Phase Chronic Myelogenous Leukemia (BP CML), and Myelodysplastic Syndrome (MDS) Relapse After Allogeneic Transplantation
NCT00548847 ·Status: COMPLETED ·Phase: PHASE2
-
Infusion of Alloreactive nk Cells for Mrd-positive Aml Patients
NCT06885476 ·Status: RECRUITING ·Phase: NA
-
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
-
CD3/CD19 Depleted or CD3 Depleted/CD56 Selected Haploid Donor Natural Killer Cell Treatment in Older AML in First Complete Remission
NCT01639456 ·Status: WITHDRAWN ·Phase: PHASE2
-
Allogeneic Cytokine-induced Killer Immunotherapy for Relapse After Allogeneic Marrow Transplant for Haematological Malignancies
NCT00460694 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Interleukin-2 in Treating Patients With Relapsed or Refractory Acute Myelogenous Leukemia
NCT00003148 ·Status: COMPLETED ·Phase: PHASE2
-
Ipilimumab After Allogeneic Stem Cell Transplant in Treating Patients With Persistent or Progressive Cancer
NCT00060372 ·Status: COMPLETED ·Phase: PHASE1
-
MG4101 for Refractory or Relapsed AML
NCT03349502 ·Status: COMPLETED ·Phase: PHASE2
-
Donor Peripheral Stem Cell Transplant in Treating Patients With Relapsed Acute Myeloid Leukemia
NCT00274846 ·Status: COMPLETED ·Phase: PHASE2
-
Haplo-identical Natural Killer (NK) Cells to Prevent Post-Transplant Relapse in AML and MDS (NK-REALM)
NCT04395092 ·Status: WITHDRAWN ·Phase: PHASE2
-
Nivolumab in AML in Remission at High Risk for Relapse
NCT02532231 ·Status: COMPLETED ·Phase: PHASE2
-
Donor Natural Killer Cells and Aldesleukin in Treating Patients w/High Risk AML Undergoing Donor Stem Cell Transplant
NCT00303667 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
INFUSION OF ALLOREACTIVE NATURAL KILLER (NK) CELLS AS CONSOLIDATION STRATEGY FOR ACUTE MYELOID LEUKEMIA PATIENTS
NCT03955848 ·Status: UNKNOWN ·Phase: NA
-
Natural Killer-cell Therapy for Acute Myeloid Leukemia
NCT04347616 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Combination Chemotherapy Followed by Melphalan and Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Acute Myeloid Leukemia
NCT00004056 ·Status: COMPLETED ·Phase: PHASE1
-
Vaccine Therapy in Treating Patients With Acute Myeloid Leukemia
NCT00100971 ·Status: TERMINATED ·Phase: PHASE1
-
Laboratory-Treated T Cells in Treating Patients With High-Risk Relapsed Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia Previously Treated With Donor Stem Cell Transplant
NCT01640301 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
CD3/CD19 Depleted or CD3 Depleted/CD56 Selected Haploidentical Donor Natural Killer (NK) Cell Based Therapy for AML Patients Not in CR
NCT03152526 ·Status: TERMINATED ·Phase: NA
-
Nivolumab and Ipilimumab After Donor Stem Cell Transplant in Treating Patients With High Risk Refractory or Relapsed Acute Myeloid Leukemia or Myelodysplastic Syndrome
NCT03600155 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Find the Highest Dose of Imetelstat in Combination With Fludarabine and Cytarabine for Patients With AML, MDS or JMML That Has Come Back or Does Not Respond to Therapy
NCT06247787 ·Status: RECRUITING ·Phase: PHASE1
-
Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Study Of NK Cell Transplantation In Newly Diagnosed Acute Myeloid Leukemia
NCT00703820 ·Status: COMPLETED ·Phase: PHASE3
-
Decitabine, Donor Natural Killer Cells, and Aldesleukin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
NCT02316964 ·Status: COMPLETED ·Phase: PHASE1
-
Haploidentical Stem Cell Transplant With or Without NK Cell Infusion in AML and MDS
NCT04166929 ·Status: TERMINATED ·Phase: PHASE2
-
Dendritic Cell/AML Fusion Cell Vaccine Following Allogeneic Transplantation in AML Patients
NCT03679650 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1