ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors
About this study
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).
- Condition
- Refractory Cancer, Recurrent Cancer, Solid Tumor, Adult, Cancer
- Tested
- IMA203 Product, IMA203 product- flat dose, IMA203CD8 Product, Nivolumab, IMADetect®
- Sponsor
- Immatics US, Inc.
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 14
- Minimum age: 18 years
- Study condition: Refractory Cancer, Recurrent Cancer, Solid Tumor, Adult, Cancer
- 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 14
- 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
Where
21 sites, 21 recruiting
Charité Benjamin Franklin - Klinik für Hämatologie und Onkologie
Berlin, Germany
Universitätsklinikum Bonn - Medizinische Klinik III
Bonn, North Rhine-Westphalia, Germany
Universitätsklinikum C.-G.-Carus Dresden
Dresden, Saxony, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Universitätsklinikum Heidelberg, Nationales Centrum für Tumorerkrankungen (NCT)
Heidelberg, Baden-Wurttemberg, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Rhineland-Palatinate, Germany
and 15 more sites on ClinicalTrials.gov
Contact
-
Immatics US, Inc.
+1 346 204-5400 ctgovinquiries@immatics.com
Potential match only. Final eligibility is determined by the study team.