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

Inclusion Criteria:

• Patients must have recurrent/progressing and/or refractory solid tumors and musthave received or not be eligible for all available indicated standard of caretreatment.

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1

• HLA-A*02:01 positive

• 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 tostudy entry until 12 months after the infusion of IMA203/IMA203CD8

• Male patient must agree to use effective contraception or be abstinent while onstudy 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 orlower prior to lymphodepletion.

Exclusion Criteria:

• History of other malignancies (except for adequately treated basal or squamous cellcarcinoma or carcinoma in situ) within the last 3 years

• Pregnant or breastfeeding

• Serious autoimmune disease Note: At the discretion of the investigator, thesepatients may be included if their disease is well controlled without the use ofimmunosuppressive 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 compromiseparticipation in the study

• History of or current immunodeficiency disease or prior treatment compromisingimmune function at the discretion of the treating physician

• Positive for HIV infection or with active hepatitis B virus (HBV) or activehepatitis C virus (HCV) infection.

• Patients with LDH greater than 2.0-fold ULN.

• Any condition contraindicating leukapheresis, lymphodepletion, low-dose IL-2, and/orIMA203/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-relatedtoxicities, defined as any Grade 3 or 4 toxicities related to prior PD1/PD-L1inhibitor therapy (e.g., atezolizumab, pembrolizumab or nivolumab etc.).

Other protocol defined inclusion/exclusion criteria could apply