IMA401 TCER® in Recurrent and/or Refractory Solid Tumors, Alone or in Combination With a Checkpoint Inhibitor

Inclusion Criteria:

• Patients must have voluntarily signed a written ICF, be able to understand andcomply with clinical trial procedures

• Patients ≥ 18 years old

• Patients must have pathologically confirmed and documented advanced and/ormetastatic NSCLC or HNSCC, other solid tumor may be considered

• Confirmed HLA status and IMA401 tumor target MAGEA4/8 expression (IMADetect®)

• Life expectancy > 2 months

• ECOG Performance Status of 0 to 1

• Measurable disease according to RECIST 1.1

• Adequate baseline hematologic, renal and hepatic function; acceptable coagulationstatus

• Patients must have recurrent and/or refractory solid tumors and must have receivedor not be eligible for all available indicated standard of care treatments

• The patient must have recovered from any side effects of prior therapy to Grade 1 orlower (except for non-clinically significant toxicities; e.g., alopecia, vitiligo)prior to treatment start. As determined by the investigator, the patient may stillbe eligible if the patient has not fully recovered from Grade ≥ 2 toxicities, incase if these toxicities are not anticipated to further improve (e.g., chronicperipheral neuropathy) and such toxicities are not anticipated to worsen with theIMA401 therapy

Exclusion Criteria:

• Other active malignancies that require treatment or that might interfere with thetrial endpoints (ongoing adjuvant anti-hormonal treatment is allowed)

• History of hypersensitivity to components of IMA401, CPI treatment or rescuemedications, contraindication for pembrolizumab

• Patients with prior allogeneic stem cell transplantation or organ transplantation

• Patients with autoimmune diseases needing disease-directed treatment

• Any serious or uncontrolled health condition, which, in the opinion of theInvestigator, would place the subject at undue risk from the study, impair theability of the subject to receive protocol specified therapy, or interfere with theinterpretation of study results

• Positive for HIV or with active hepatitis B or C infection.

• Patients with active infection

• Systemic corticosteroids (≥ 10 mg/day prednisone or equivalent) received 2 weeksprior to starting trial treatment

• Patients with active brain metastases and leptomeningeal metastases