TrialPath
← Back to searchRecruiting

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

NCT03686124 · Immatics US, Inc.
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
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
About this study
SCREENING: Patient eligibility will be determined by protocol inclusion/exclusion criteria including HLA (human leukocyte antigen) screening and a biopsy (or collection of archival tumor tissue) for biomarker screening. If the patient is eligible, white blood cells will be taken during leukapheresis for the manufacture of IMA203 or IMA203CD8 product. MANUFACTURING: IMA203 or IMA203CD8 products will be made from the patients' white blood cells. TREATMENT: Lymphodepletion with cyclophosphamide and fludarabine will occur in the days before the IMA203/IMA203CD8 product infusion to improve the duration of time that IMA203/IMA203CD8 product stays in the body. The patient will be admitted to the hospital during the T-cell infusion. After the IMA203/IMA203CD8 product infusion, if applicable, a low dose of IL-2 will be given subcutaneously until day 10. In Extension Cohort B (IMA203) nivolumab will be administered intravenously. Patients will be monitored closely throughout the study. The follow-up phase ends 5 years post infusion.
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 * 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 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
Study design
Enrollment target: 375 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2019-05-14
Estimated completion: 2032-06
Last updated: 2026-04-13
Interventions
Biological: IMA203 ProductBiological: IMA203 product- flat doseBiological: IMA203CD8 ProductDrug: NivolumabDevice: IMADetect®
Primary outcomes
  • Phase 1: Determine the MTD and/or recommended dose for extension for IMA203/IMA203CD8 (28 days)
  • Phase 1 and Phase 2: Number and grade of treatment emergent adverse events and adverse events of special interest in subjects treated. (35 days)
  • Phase 1 and Phase 2: Tumor Response (5 years)
Sponsor
Immatics US, Inc. · industry
Contacts & investigators
ContactImmatics US, Inc. · contact · ctgovinquiries@immatics.com · +1 346 204-5400
InvestigatorCedrik Britten, M.D. · study_director, Immatics US, Inc.
All locations (21)
Stanford Cancer InstituteRecruiting
Stanford, California, United States
University of Colorado, Anschutz Medical CampusActive Not Recruiting
Aurora, Colorado, United States
University of Miami Hospital and ClinicsRecruiting
Miami, Florida, United States
University of Chicago Medical CenterActive Not Recruiting
Chicago, Illinois, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer CenterActive Not Recruiting
New York, New York, United States
Ohio State University Wexner Medical Center Gynecologic Oncology at Mill RunRecruiting
Columbus, Ohio, United States
University of Pennsylvania, Perelamn Center for Advanced MedicineRecruiting
Philadelphia, Pennsylvania, United States
Thomas Jefferson University, Honickman CenterActive Not Recruiting
Philadelphia, Pennsylvania, United States
Fox Chase Cancer CenterRecruiting
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical CenterRecruiting
Pittsburgh, Pennsylvania, United States
University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Fred Hutchinson Cancer CenterActive Not Recruiting
Seattle, Washington, United States
Universitätsklinikum Heidelberg, Nationales Centrum für Tumorerkrankungen (NCT)Recruiting
Heidelberg, Baden-Wurttemberg, Germany
Klinikum rechts der Isar der Technischen Universität MünchenRecruiting
Munich, Bavaria, Germany
Universitätsklinikum WürzburgRecruiting
Würzburg, Bavaria, Germany
Universitätsklinikum Bonn - Medizinische Klinik IIIRecruiting
Bonn, North Rhine-Westphalia, Germany
Universitätsmedizin der Johannes Gutenberg-Universität MainzRecruiting
Mainz, Rhineland-Palatinate, Germany
Universitätsklinikum C.-G.-Carus DresdenRecruiting
Dresden, Saxony, Germany
Charité Benjamin Franklin - Klinik für Hämatologie und OnkologieRecruiting
Berlin, Germany
Universitätsklinikum Hamburg-EppendorfRecruiting
Hamburg, Germany