Phase I Trial of Vididencel in CML-CP Patients With MRD Under TKI Treatment

Exclusion Criteria

• •Participants who are scheduled for allogeneic stem cell transplantation (allo HSCT) or participants who have undergone allo HSCT less than 5 years ago. Participants who have undergone allo HSCT more than 5 years ago and had any sign of graft-versus-host disease.
• •Uncontrolled or serious infections.
• •Ongoing systemic immunosuppressive therapy, other than short use of low dose steroids, i.e. equivalent to an average dose of ≤10 mg of prednisone/day.
• •Use of any other experimental drug or therapy within 28 days or 5 half-lives of the investigational drug, whichever is longer of baseline.
• •Active autoimmune disease or participants with recent history, except for well controlled diabetes and stable thyroid disease.
• •Inadequate liver function (AST and ALT \> 3 x upper limit of normal (ULN), serum bilirubin \>3 x ULN).
• •Other active malignancies within the last 5 years, except for adequately treated carcinoma in situ of the cervix or non-melanoma carcinoma of the skin.
• •Pregnant or lactating females.
• •Major surgical procedure (including open biopsy) within 28 days prior to the first study treatment, or anticipation of the need for major surgery during the course of the study treatment.
• •Evidence of any other medical conditions (such as psychiatric illness, physical examination or laboratory findings) that may interfere with the planned treatment, affect participant compliance or place the participant at high risk from treatment-related complications.
• •Known HIV, Hepatitis B and/or Hepatitis C infections.
• •Known hypersensitivity to vididencel, or any of the ingredients or excipient in the formulation.
• •Participants who, in the opinion of the Investigator, would clinically benefit from switching to an alternative TKI therapy