Tests modified T cells with or without nivolumab in adults with solid tumors
Tests modified T cells, alone or with nivolumab, in adults with PRAME-expressing solid tumors.
Plain-language title generated from the registry record
Registry title: ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors
Key facts
- Where
- Berlin, Bonn, Dresden, Hamburg, Heidelberg, Mainz, Munich, and Würzburg, GermanySee the 8 sites
- Phase
- Phase 1/2
Where in Germany
- Charité Benjamin Franklin - Klinik für Hämatologie und OnkologieBerlin, GermanyTaking people
- Universitätsklinikum Bonn, Medizinische Klinik IIIBonn, GermanyTaking people
- Universitätsklinikum C.-G.-Carus DresdenDresden, GermanyTaking people
- Universitätsklinikum Hamburg-EppendorfHamburg, GermanyTaking people
- Universitätsklinikum Heidelberg, Nationales Centrum für Tumorerkrankungen (NCT)Heidelberg, GermanyTaking people
- Universitätsmedizin der Johannes Gutenberg-Universität MainzMainz, GermanyTaking people
- Klinikum rechts der Isar der Technischen Universität MünchenMunich, GermanyTaking people
- Universitätsklinikum WürzburgWürzburg, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Immatics US, Inc.
- Trial code
- NCT03686124
- Record updated
- 13 May 2026
- Original description
The study's purpose is to establish the safety and tolerability of IMA203/IMA203CD8 products with or without combination with nivolumab in patients with solid tumors that express preferentially expressed antigen in melanoma (PRAME).Read full original descriptionShow less
Phase 1/2 Study Evaluating Genetically Modified Autologous T Cells Expressing a TCR Recognizing a Cancer/Germline Antigen as Monotherapy or in Combination With Nivolumab in Patients With Recurrent and/or Refractory Solid Tumors
The study's purpose is to establish the safety and tolerability of IMA203/IMA203CD8 products with or without combination with nivolumab in patients with solid tumors that express preferentially expressed antigen in melanoma (PRAME).
Inclusion: 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; For patients with ovarian/fallopian tube cancer only: Patients must have confirmed diagnosis of high-grade serous or endometrioid epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer; For patients with endometrial carcinoma only: Patients must have a histologically confirmed diagnosis of recurrent or persistent endometrial carcinoma; Measurable disease according to RECIST 1.1; Adequate selected organ function per protocol; Patient's tumor must express tumor antigen by "IMADetect® RT-qPCR. Retrospective testing will be required for patients that qualify; 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: 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; 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; History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years; 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; Positive for HIV infection or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection; Any condition contraindicating leukapheresis, lymphodepletion, low-dose IL-2, and/or IMA203/IMA203CD8 treatment; Patients with LDH greater than 2.0-fold ULN; Pregnant or breastfeeding; Patients with active brain metastases.