A Safety Study of Human Cord Blood Derived, Culture-expanded, Natural Killer Cell (PNK-007) Infusion With or Without Subcutaneous Recombinant Human Interleukin-2 (rhIL-2) Following Autologous Stem Cell Transplant for Multiple Myeloma (MM)

The presence of any of the following will exclude a subject from enrollment:

1. Subject has plasma cell leukemia.

2. Subject has non-secretory myeloma.

3. Subject has previously undergone allogeneic stem cell transplant.

4. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.

5. Subject has any condition including the presence of laboratory abnormalities which places the subject at unacceptable risk if he or she were to participate in the study.

6. Subject has any condition that confounds the ability to interpret data from the study.

7. Subject has a body weight exceeding 120 kg.

8. Subject has aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase ≥ 2.5 x the upper limit of normal (ULN) at screening.

9. Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2 at screening calculated using the Modification of Diet in Renal Disease Study equation.

10. Subject has a bilirubin level \> 2 mg/dL (unless subject has known Gilbert's disease) at screening.

11. Subject has had prior treatment with biologic antineoplastic agents no less than 7 days before PNK-007 infusion and at least 5 half-lives. For agents that have known AEs occurring beyond 7 days after administration (ie, monoclonal antibodies), this period must be extended beyond the time during which acute AEs are known to occur.

12. Subject is pregnant or breastfeeding.

13. Subject has new or progressive pulmonary infiltrates or pleural effusion large enough to be detected by chest x-ray or computed tomography (CT) scan.

14. Subject has active autoimmune disease other than controlled connective tissue disorder or those who are not on active therapy.

15. Subject has human immunodeficiency virus (HIV) are excluded due to increased risk of lethal infections when treated with myeloablative chemotherapy.

16. Subject has history of malignancy, other than multiple myeloma (MM), unless the subject has been free of disease for \> 3 years from the date of signing the ICF. Exceptions include the following:

1. Basal cell carcinoma of the skin

2. Squamous cell carcinoma of the skin

3. Carcinoma in situ of the cervix

4. Carcinoma in situ of the breast

5. Incidental histological finding of prostate cancer (TNM stage of T1a or T1b)

17. Subject has a history of severe asthma and is presently on chronic medications or has a history of other symptomatic pulmonary disease.

18. Untreated chronic infection or treatment of any infection with systemic antibiotics within 2 weeks prior to melphalan.

19. Subject has any other organ dysfunction that will interfere with the administration of the therapy according to this protocol.

20. Subject has a resting left ventricular ejection fraction (LVEF) of \< 35% obtained by echocardiography or multigated acquisition scan (MUGA).

21. Subject was treated with an investigational product no less than 28 days before PNK-007 infusion. Subject must no longer be a participant in the previous interventional study at the time of the PNK-007 infusion.

What this study is about