ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors

Eligibility Criteria

• * Patients must have recurrent/progressing and/or refractory solid tumors and must have received or not be eligible for all available indicated standard of care treatment.
• * Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• * HLA phenotype positive for the study
• * Measurable disease according to RECIST 1.1
• * Adequate selected organ function per protocol
• * Patient's tumor must express tumor antigen by "IMADetect® RT-qPCR
• * Life expectancy more than 5 months
• * Female patient of childbearing potential must use adequate contraception prior to study entry until 12 months after the infusion of IMA203/IMA203CD8
• * Male patient must agree to use effective contraception or be abstinent while on study and for 6 months after the infusion of IMA203/IMA203CD8
• * The patient must have recovered from any side effects of prior therapy to Grade 1 or lower prior to lymphodepletion.
• * History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years
• * Pregnant or breastfeeding
• * Serious autoimmune disease Note: At the discretion of the investigator, these patients may be included if their disease is well controlled without the use of immunosuppressive agents.
• * History of cardiac conditions as per protocol
• * Prior stem cell transplantation or solid organ transplantation
• * Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study
• * History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician
• * Positive for HIV infection or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.
• * Patients with LDH greater than 2.0-fold ULN.
• * Any condition contraindicating leukapheresis, lymphodepletion, low-dose IL-2, and/or IMA203/IMA203CD8 treatment
• * Patients with active brain metastases
• * Concurrent treatment in another clinical trial.
• * For nivolumab treatment, patients must not have a history of severe immune-related toxicities, defined as any Grade 3 or 4 toxicities related to prior PD1/PD-L1 inhibitor therapy (e.g., atezolizumab, pembrolizumab or nivolumab etc.).