IMA401 TCER® in Recurrent and/or Refractory Solid Tumors

This is an interventional treatment trial for Refractory Cancer Read More

Inclusion Criteria:

• Patients must have voluntarily signed a written ICF, be able to understand and comply with clinical trial procedures
• Patients ≥ 18 years old
• Patients must have pathologically confirmed and documented advanced and/or metastatic solid tumor
• Confirmed HLA status and IMA401 tumor target MAGEA4/8 expression (IMADetect®)
• Life expectancy > 2 months
• ECOG Performance Status of 0 to 2
• Measurable disease according to RECIST 1.1
• Adequate baseline hematologic, renal and hepatic function; acceptable coagulation status
• Patients must have recurrent and/or refractory solid tumors and must have received or 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 or lower (except for non-clinically significant toxicities; e.g., alopecia, vitiligo) prior to treatment start. As determined by the investigator, the patient may still be eligible if the patient has not fully recovered from Grade ≥ 2 toxicities, in case if these toxicities are not anticipated to further improve (e.g., chronic peripheral neuropathy) and such toxicities are not anticipated to worsen with the IMA401 therapy

Exclusion Criteria:

• Other active malignancies that require treatment or that might interfere with the trial endpoints (ongoing adjuvant anti-hormonal treatment is allowed)
• History of hypersensitivity to components of IMA401 or rescue medications, if no alternative treatment option is available
• 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 the Investigator, would place the subject at undue risk from the study, impair the ability of the subject to receive protocol specified therapy, or interfere with the interpretation of study results
• Active infection by human immunodeficiency virus, hepatitis B or C
• Patients with any clinically relevant, active viral infection
• Systemic corticosteroids (≥ 10 mg/day prednisone or equivalent) received 2 weeks prior to starting IMA401 therapy
• Patients with active brain metastases