Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NK cells · 1 trial · 2 indications
as defined by International NB Response Criteria. Disease status is defined by the International NB Response Criteria. Complete response/remission (CR): no evidence of disease. Very good partial response/remission (VGPR): \>90% decrease in all disease parameters, except bone scan unchanged or improved; bone marrow must be free of disease. Partial response/remission: \>50% decrease in all disease parameters, except bone scan unchanged or improved; no more than 1 positive bone marrow site. Mixed response: \>50% decrease in \>1 but not all disease markers. Stable disease: \<50% decrease in all tumor markers. Progressive disease: new lesion, or \>25 % increase in any disease marker.
| Arm | Type | Description |
|---|---|---|
| Humanized Anti-GD2 Antibody Hu3F8 | EXPERIMENTAL | This is a phase I study to assess the safety and feasibility of combining HLA-mismatched (KIR ligand incompatible) NK cells with hu3F8 in high-risk NB patients. Following chemotherapy, patients will be treated in sequential groups with a minimum of 3 patients/ dose of NK cells. Three dose levels of NK cells, starting at dose level 1, will be evaluated in this treatment protocol. The goal dose for each dose level is the high boundary (e.g. 9.9x10\^6/kg in level 1; 14.9x10\^6/kg in level 2, etc), but a range is provided to allow for cases where the goal dose cannot be achieved. |
| Name | Type | Description |
|---|---|---|
| cyclophosphamide | DRUG | chemotherapy with intravenous (IV) cyclophosphamide 50mg/kg/day (for patients with body weight\<70kg) or 1500mg/m\^2/day (for patients with body weight ≥70kg) for two days (days -6 and -5). |
| NK cells | BIOLOGICAL | Day 0: NK cell infusion. NK cells are resuspended in Normasol at a concentration no less than 5 x 10\^6cells/mL. The patient is pre-medicated as per standard cell product infusion. The cell product is infused through a central venous catheter. Patients will be evaluated clinically by vital signs pre- and approximately 30 minutes post infusion of NK cells and thereafter at approximately 1 hour intervals for 4 hours. |
| hu3F8 | BIOLOGICAL | On Days -1, +1, +5, +7 and +9 hu3F8 is administered at 1.68 mg/kg/day and infused over \~30-90 minutes |
| rIL-2 | DRUG | On day 0, daily from +2 through +4, day +6, and day +8, rIL-2 is administered subcutaneously at 6 x 10\^5 U/m\^2/day. |
Inclusion Criteria: * Diagnosis of NB as defined by international criteria,.e., histopathology (confirmed by the MSKCC Department of Pathology) or bone marrow metastases plus high urine catecholamine levels. * High-risk NB as defined by risk-related treatment guidelines1 and the International NB St...
NK cells, developed by Y-mAbs Therapeutics, Inc. (YMAB), are being studied for the treatment of high-risk neuroblastoma. The therapy combines an anti-GD2 antibody with allogeneic natural killer cells. It is currently in Phase 1 clinical development as an investigational oncology treatment.
NK cells therapy involves the use of allogeneic natural killer cells in combination with a humanized anti-GD2 antibody (Hu3F8). The antibody targets GD2, a tumor-associated antigen expressed on neuroblastoma cells, while the NK cells provide an additional immune-mediated attack on the tumor.
NK cells is being developed by Y-mAbs Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol YMAB. The company is conducting clinical research on this therapy for high-risk neuroblastoma.
NK cells is in Phase 1 clinical development. A Phase 1 trial (NCT02650648) has been completed, evaluating the safety and efficacy of the therapy in patients with high-risk neuroblastoma. The drug is investigational and has not yet received FDA approval.
NK cells has been studied in one clinical trial, NCT02650648, titled 'Humanized Anti-GD2 Antibody Hu3F8 and Allogeneic Natural Killer Cells for High-Risk Neuroblastoma.' This Phase 1 trial was completed in the United States and enrolled 85 participants with high-risk neuroblastoma.
NK cells therapy is not the same as Hu3F8 alone. The treatment combines Hu3F8, a humanized anti-GD2 antibody, with allogeneic natural killer cells. The combination is being studied to enhance the immune response against neuroblastoma, whereas Hu3F8 is the antibody component of this investigational therapy.