Study staff must take care to minimize temperature excursions during transfer of the product from shipping containers to controlled liquid nitrogen storage on site. Drug product s will not be retrieved from cryogenic storage until the study subject is present and available for dosing. When removing a product carton from storage to retrieve a vial for dosing, any doses remai ning in the carton will be returned to cryogenic storage immediately. Study drugs must be administered within 2 hours of retrieval from the dew ar (cryogenic storage). Stability studies for HS-130 are currently ongoing and clinical sites will be notified of storage information and/or shelf life change. The instructions for preparation, administration , stability and storage of HS -110 to be used in combination with HS -130 will reference instructions per the Investigational Product Manual . 6.1.1 Dose Escalation Sc heme Escalating doses of the viable, replication-incompetent, human whole cell vaccines, HS-130 and HS -110 will be administered to patients via intradermal injections /re-injections (up to 10 total ) on Day 1 of a two - Heat Biologics Protocol No. HS130 -001 A Phase I Study of HS -130 in combination with HS-110 in patients with solid tumors HS130- 001 32 of 60 Version 2.0 - 11 Feb 2020 Confidential - Entire Page week cycle. The length of each cycle is two weeks, and the DLT window of observation includes the safety data obtained from the first two treatment cycles, Cycle 1 and Cycle 2 ( 4 weeks ). Seven dose levels will be explored, and patients will receive separate escalating doses of HS-130 and HS- 110 in alternating fixed 1:1 or 2:1 ratio based on the amount of secreted OX40L -Ig (HS -130) and gp96 -Ig fusion protein (HS -110) per cell of the drug product. The starting dose of HS -130/HS -110 combination is based on the dose-ranging studies conducted in animal model s of T cell expansion and tumor challenge, as well as established clinical experience from HS-110. Table 2: HS-130/HS -110 Dose Levels Cohort Dose level HS-130 dose* (ng/24- hr OX40L - Ig) HS-110 dose* (ng/24- hr gp96 - Ig) HS-130: HS-110 Ratio Total number of AD100 cells (Q2W)# Minimum number of patients 1 -1 75 ng/24 -hr 75 ng/24 -hr 1:1 1.0 million 1 1 150 ng/24 -hr 150 ng/24 -hr 1:1 1.9 million 1 2 300 ng/24 -hr 150 ng/24 -hr 2:1 2.3 million 1 3 300 ng/24 -hr 300 ng/24 -hr 1:1 3.8 million 1 4 600 ng/24 -hr 300 ng/24 -hr 2:1 4.7 million 1 2 5 600 ng/24 -hr 600 ng/24 -hr 1:1 7.6 million 3 3 6 1,200 ng/24 -hr 600 ng/24 -hr 2:1 9.3 million 3 4 7 1,200 ng/24 -hr 1,200 ng/24 -hr 1:1 15.1 million 3 *The number of cells administered to achieve the HS- 130 ( ng/24- hr of OX40L- Ig protein) and HS- 110 ( ng/24- hr of gp96 -Ig protein) dose will be determined based on the specifications for that batch of the drug product . For HS -130: Lot HBI-HS-130- FP-001 = 241 fg/cell/24 -hr and HS- 110: Lot 0000748931 = 104 fg/cell/24- hr. The productivity per cell will be determined using the same assay format and standards for pre -clinical and clinical derived material. # The suggested total number of allogeneic tumor cells (AD1 00) administered every second week at the highest dose level is similar to or less than the weekly dose of 10 million HS -110 cells that has been established safe and immunologically effective in the HS -110 study (NCT02439450, IND No. 14814).