PHARMACEUTICAL INFORMATION A list of the adverse events and potential risks associated with the investigational agent administered in this study can be found in Section 8.1 . 8.1 CTEP IND Agent(s): N/A 8.2 Other Investigational Agent Recombinant Gl ycosylated Human Interleukin -7, (CYT107) rhIL -7 Product description : Interleukin -7 (IL -7) is a multifunctional cytokine, mainly produced by non -hematopoietic cells, which is active on T cell development, expansion, response and protection from apoptosis. IL -7 has a critical and, at some steps, a non -redundant stimulating ef fect on T lymphocyte development, notably on thymopoiesis and downstream from the thymus, on homeostasis expansion of peripheral T cells. NCI Protocol #: CITN12 -03 Version Date: July 26, 2017 31 CYT107, developed by Cytheris SA and owned by RevImmune, Inc. , is a glycosylated recombinant human IL -7 produced from a recombinant Chinese Hamster Ovary (CHO) cell line (CHO S). Chemical Name or Amino Acid Sequence: CYT107 (rhIL -7) Drug Substance is a glycosylated 152 amino acid recombinant protein (same as the native protein) which comprises three putative N -glycosyla tion sites and one putative O -glycosylation site. The composition of CYT107 includes a majority of rhIL -7 polypeptides which are glycosylated on at least three distinct amino acid residues (2 to 3 N - glycans and one O -glycan) and a minority of di -glycosylat ed rhIL -7 polypeptide (one N - glycan and one O -glycan). CYT107 has 3 disulfide bridges: Cys2 - Cys 92, Cys 34 - Cys 129, and Cys 47 - Cys 141. Molecular Weight: CYT107 has an average molecular mass, as determined by mass spectrometry, of 22kDa; correspondin g to an average apparent molecular weight of 27kDa as determined by SDS gel electrophoresis. Solution preparation : CYT107 (rhIL -7) Drug Product is supplied in 2 cc vials as a colorless solution suitable for subcutaneous administration, formulated at a concentration of 2 mg/ml in the following buffer: 10mM sodium acetate, 100 mM NaCl, 50mM glutamic acid, and 50mM arginine. The pH of the solution is in the range of 4.8 and 5.2 . Vials are filled to deliver 1 mg/0.5 mL of CYT107. Storage requirements: CYT107 should be stored at -20°C. Store vials of CYT107 according to instructions on the label. Stability: Stability studies are ongoing and will be continued throughout the clinical study. Regular updates are submitted to the FDA through quality amendments. Stability information will be periodically communicated to the Hospital Pharmacy, to guarantee the stability of the drug product. The vial is for 1 injection only and any unused portion should not be re -used for a subject or for other purpose. Consideration for safe handling and administration: There are no specific guidelines for the safe handling of CYT107 Drug Product. Institutional guidelines for safe handling of proteins in general should be followed. Do not shake vials before injection . CYT107 should be administered slowly and strictly in the subcutaneous space . Route of administration: CYT107 will be administered subcutaneously, which according to studies in monkeys, yields satisfactory bioavailability (> 75%), with an extended kinetic profile that may favor NCI Protocol #: CITN12 -03 Version Date: July 26, 2017 32 prolonged IL -7 activity. Dose adjustment: The appropriate quantity of CYT107 to be given at each injection will depend on the patient’s weight and dose level. For obese patients, a corrected weight will be used to calculate the final dose the patient will receive. Carefully check dose and dosing r egimens before CYT107 administration (See Appendix D). Agent Ordering and Agent Accountability: CYT107 is produced in the USA by Laureate Biopharm aceuticals now operating as Patheon® . After manufacturing, the product is stored at CSM in Fargo, ND for clinical supply, packaging, and labeling. The label indicates the product name, strength, manufacturing date, and the study requirement information. CYT107 will be shipped from CSM to each participating site. (See the Stud y Procedures Manual for instructions on how to order CYT107 ). Agent Inventory Records : The investigator, or a responsible party designated by the investigator (e.g. institutional investigational pharmacy) , must maintain a careful record of the inventory and disposition of all agents received from CSM in Fargo, ND using the Study Agent Drug Accountability Record. (See the Study Procedures Manual for the form to use and ins tructions on how to complete it ).