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

Launched by IMMATICS US, INC. · Sep 25, 2018

Keywords

ClinConnect Summary

This clinical trial, called ACTengine® IMA203/IMA203CD8, is researching a new treatment for adults with solid tumors that are difficult to treat, specifically those that keep coming back or have not responded to other therapies. The study is looking at a product called IMA203/IMA203CD8, which may be used alone or together with another drug called nivolumab. The main goal is to find out if these treatments are safe and well-tolerated by patients.

To be eligible for this trial, participants must have a specific type of solid tumor and have already tried all available standard treatments or not be eligible for them. Candidates should have a good performance status, meaning they are relatively healthy and active, and their tumors must express a specific antigen (a substance that triggers an immune response). Participants can expect to undergo some tests and procedures to ensure they meet the criteria before starting treatment, and they will need to follow specific guidelines regarding contraception if they are of childbearing potential. This trial is currently recruiting participants, so if you or someone you know is interested, it may be worth discussing with a healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion 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-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 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.
• Exclusion Criteria:
• • 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.).
• • Other protocol defined inclusion/exclusion criteria could apply