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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with solid tumors that came back, grew, or did not respond to treatment, and whose tumor shows the PRAME marker. They must also be HLA-A*02:01 positive.
- Age
- 18 years and older
- Sex
- All sexes can join
- Disease stage
- Solid tumors that came back, are growing, or did not respond. People must have had or cannot have all standard treatments. Measurable disease (RECIST 1.1). Ovarian, fallopian tube or peritoneal cancer must be high-grade serous or endometrioid. Endometrial cancer must be recurrent or persistent.
- Earlier treatment
- Must have had, or not be able to have, all available standard treatments. Side effects of earlier treatment must be Grade 1 or lower before lymphodepletion. For nivolumab, no Grade 3 or 4 side effects from earlier PD1/PD-L1 inhibitor treatment.
- Biomarker or test result
- HLA-A*02:01 positive. The tumor must show the tumor antigen on the IMADetect® RT-qPCR test.
Main reasons for not taking part
- Another cancer within the last 3 years (some skin and in situ cancers excepted)
- Pregnant or breastfeeding
- Prior stem cell or solid organ transplant
- HIV infection, or active hepatitis B or C
- Active brain metastases
Read by machine on 12 November 2026.
Where in Germany
- Charité Benjamin Franklin - Klinik für Hämatologie und OnkologieBerlin, GermanyContact: Immatics US, Inc.Taking people
- Universitätsklinikum Bonn, Medizinische Klinik IIIBonn, GermanyContact: Immatics US, Inc.Taking people
- Universitätsklinikum C.-G.-Carus DresdenDresden, GermanyContact: Immatics US, Inc.Taking people
- Universitätsklinikum Hamburg-EppendorfHamburg, GermanyContact: Immatics US, Inc.Taking people
- Universitätsklinikum Heidelberg, Nationales Centrum für Tumorerkrankungen (NCT)Heidelberg, GermanyContact: Immatics US, Inc.Taking people
- Universitätsmedizin der Johannes Gutenberg-Universität MainzMainz, GermanyContact: Immatics US, Inc.Taking people
- Klinikum rechts der Isar der Technischen Universität MünchenMunich, GermanyContact: Immatics US, Inc.Taking people
- Universitätsklinikum WürzburgWürzburg, GermanyContact: Immatics US, Inc.Taking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.