drugset / Trial / NCT02727803
Personalized NK Cell Therapy in CBT
Phase 2
Recruiting
100 enrolled
M.D. Anderson Cancer Center
National Cancer Institute (NCI) · collab
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2016-05-19
- Primary completion
- 2027-05-31
- Completion
- 2027-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NK-92/5.28.z | Cell therapy | — | Intravenous |
| Background | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | — | Intravenous |
| Background | Busulfan | Small molecule | — | Intravenous |
| Background | Clofarabine | Other / unclassified | — | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Fludarabine | Small molecule | — | Intravenous |
| Background | Melphalan | Small molecule | — | Intravenous |
| Background | Rituximab | Monoclonal antibody | — | Intravenous |
Indications
B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2)
Hodgkins lymphoma
acute biphenotypic leukemia
acute myeloid leukemia with multilineage dysplasia
acute myeloid leukemia, MLL gene rearrangement
adult acute lymphoblastic leukemia
chronic myelomonocytic leukemia
high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement
leukemia, myeloid, accelerated-phase
myelodysplastic syndrome with excess blasts
plasma cell myeloma