NCT02727803

Personalized NK Cell Therapy in CBT

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 15 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This phase II clinical trial studies how well personalized natural killer (NK) cell therapy works after chemotherapy and umbilical cord blood transplant in treating patients with myelodysplastic syndrome, leukemia, lymphoma or multiple myeloma. This clinical trial will test cord blood (CB) selection for human leukocyte antigen (HLA)-C1/x recipients based on HLA-killer-cell immunoglobulin-like receptor (KIR) typing, and adoptive therapy with CB-derived NK cells for HLA-C2/C2 patients. Natural killer cells may kill tumor cells that remain in the body after chemotherapy treatment and lessen the risk of graft versus host disease after cord blood transplant.

Detailed description

PRIMARY OBJECTIVES: I. Progression-free survival (PFS) time. SECONDARY OBJECTIVES: I. Overall survival (OS) time. II. Transplant related mortality (TRM). III. Graft versus host disease (GVHD). IV. Infection OUTLINE: Patients are assigned to 1 of 3 preparative regimens. MYELOABLATIVE REGIMEN 1: Patients receive anti-thymocyte globulin intravenously (IV) over 4 hours on days -9 and -8, fludarabine phosphate IV over 1 hour, clofarabine IV over 1 hour, and busulfan IV over 3 hours on days -7 to -4. Patients undergo total body irradiation (TBI) on day -3. NON-MYELOABLATIVE REGIMEN 2: Patients with cluster of differentiation (CD)20 positive malignancies receive rituximab IV over 6 hours on day -9. Patients receive anti-thymocyte globulin IV over 4 hours on days -8 and -7, fludarabine phosphate IV over 1 hour on days -6 to -3, and cyclophosphamide IV over 3 hours on day -6 and undergo TBI on day -1 at the discretion of the investigator(s). REDUCED INTENSITY REGIMEN 3: Patients receive anti-thymocyte globulin IV over 4 hours on days -7 and -6, fludarabine phosphate IV over 1 hour on days -5 to -2, and melphalan IV over 30 minutes on day -2. UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo umbilical cord blood transplantation on day 0. NK CELLS INFUSION: Patients receive NK cells IV over 30 minutes between days 30-180. After completion of study treatment, patients are followed up at 1, 7, 14, 28, 45, 60, and 100 days, and at 6, 9, and 12 months, and then yearly for up to 4 years.

Conditions

• Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Acute Biphenotypic Leukemia
• Acute Lymphoblastic Leukemia
• Acute Lymphoblastic Leukemia in Remission
• Acute Myeloid Leukemia With Myelodysplasia-Related Changes
• Acute Myeloid Leukemia With Variant MLL Translocations
• B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
• Chemotherapy-Related Leukemia
• Chronic Myelomonocytic Leukemia
• Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
• ISS Stage II Plasma Cell Myeloma
• ISS Stage III Plasma Cell Myeloma
• Myelodysplastic Syndrome
• Myelodysplastic Syndrome With Excess Blasts
• Myelodysplastic Syndrome With Gene Mutation
• Myelodysplastic/Myeloproliferative Neoplasm
• Previously Treated Myelodysplastic Syndrome
• Recurrent Acute Myeloid Leukemia
• Recurrent Adult Acute Myeloid Leukemia
• Recurrent Hodgkin Lymphoma
• Recurrent Non-Hodgkin Lymphoma
• Refractory Acute Lymphoblastic Leukemia
• Refractory Adult Acute Lymphoblastic Leukemia
• Secondary Acute Myeloid Leukemia
• Therapy-Related Myelodysplastic Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	Allogeneic Natural Killer Cell Line NK-92	Given IV
BIOLOGICAL	Anti-Thymocyte Globulin	Given IV
DRUG	Busulfan	Given IV
DRUG	Clofarabine	Given IV
DRUG	Cyclophosphamide	Given IV
DRUG	Fludarabine Phosphate	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Melphalan	Given IV
BIOLOGICAL	Rituximab	Given IV
RADIATION	Total-Body Irradiation	Undergo total body irradiation
PROCEDURE	Umbilical Cord Blood Transplantation	Undergo umbilical cord blood transplantation

Timeline

• Start date: 2016-05-19
• Primary completion: 2027-05-31
• Completion: 2027-05-31
• First posted: 2016-04-05
• Last updated: 2025-11-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study