Personalized NK Cell Therapy in CBT

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.

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

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Warren Fingrut, MD · M.D. Anderson Cancer Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-05-19

Primary Completion

2027-05-31

Completion

2027-05-31

FDA Drug

Yes

Countries

• United States

Study Locations