Safety and Efficacy of CMD03 CAR T Cell in Children With Relapse or Refractory Solid Tumors

Prior treatment

• Serologic status reflecting active HIV, hepatitis B or C infection. Participants who are positive for hepatitis B core antibody, hepatitis B surface antigen or hepatitis C antibody must have negative PCR prior to enrollment.

Other illness

• Presence of greater than or equal to grade 3 cardiac dysfunction or symptomatic arrythmia requiring intervention
• Presence of primary immunodeficiency or bone marrow failure syndrome
• Presence of uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities, or psychiatric illness/social situations that would limit compliance with study requirements

Lab values

• Pregnant or breastfeeding women were excluded from this study because CAR-T cell therapy may be associated with the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a negative serum pregnancy test. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAR-T cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study. Participants of childbearing or child-fathering potential must be willing to practice birth control from the time of enrollment in this study and for four months after receiving CAR-T-cell infusion.

• Participants must have B7-H3 positive solid tumor with measurable disease.
  • \- B7-H3 expression will be evaluated by standard immunohistochemistry (IHC) or flow cytometry using a previously obtained sample.
• Evidence of relapsed or refractory disease after standard first-line therapy
• Age 1 - 25 years
• Sex: Male or female
• Performance status: Lansky or Karnofsky score not less than 50
• Life expectancy not less than 12 weeks
• Normal organ function
  • AST (SGOT) below 5 times the upper limit of normal (ULN)
  • ALT (SGPT) below 5 times the upper limit of normal (ULN)
  • Total bilirubin below 3 times the upper limit of normal (ULN)
  • Creatinine below 5 times the upper limit of normal (ULN)
  • SpO2 room air not less than 90%
• Prior therapy wash-out before planned leukapheresis
  • Not less than 7 days post last chemotherapy/biologic therapy administration
  • 3 half-lives or 30 days, whichever is shorter after the last dose of antitumor antibody therapy
  • At least 30 days from most recent cellular infusion
  • All systemically administered corticosteroid treatment therapy must be stable or decreasing within 1 week prior to enrollment with a maximum of 0.5 mg/kg/day dose of methylprednisolone. Corticosteroid physiologic replacement therapy is allowed
• Participants and/or legal guardians must have the ability to understand and willingness to sign a written informed consent and/or assent document