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

Recruiting now · Phase 1/Phase 2

Conditions studied: Refractory Cancer, Recurrent Cancer, Solid Tumor, Adult, Cancer

In brief

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).

Key facts

Study ID

NCT03686124

Run by

Immatics US, Inc.

People needed

375

Starts

2019-05-14

Expected to finish

2032-06-01

Last updated by the study team

2026-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Stanford Cancer Institute — Stanford, California, United States (enrolling)
• University of Colorado, Anschutz Medical Campus — Aurora, Colorado, United States (enrolling)
• University of Miami Hospital and Clinics — Miami, Florida, United States (enrolling)
• University of Chicago Medical Center — Chicago, Illinois, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Ohio State University Wexner Medical Center Gynecologic Oncology at Mill Run — Columbus, Ohio, United States (enrolling)
• University of Pennsylvania, Perelamn Center for Advanced Medicine — Philadelphia, Pennsylvania, United States (enrolling)
• Thomas Jefferson University, Honickman Center — Philadelphia, Pennsylvania, United States (enrolling)
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (enrolling)
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (enrolling)
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Fred Hutchinson Cancer Center — Seattle, Washington, United States (enrolling)
• Universitätsklinikum Heidelberg, Nationales Centrum für Tumorerkrankungen (NCT) — Heidelberg, Baden-Wurttemberg, Germany (enrolling)
• Klinikum rechts der Isar der Technischen Universität München — Munich, Bavaria, Germany (enrolling)
• Universitätsklinikum Würzburg — Würzburg, Bavaria, Germany (enrolling)
• Universitätsklinikum Bonn - Medizinische Klinik III — Bonn, North Rhine-Westphalia, Germany (enrolling)
• Universitätsmedizin der Johannes Gutenberg-Universität Mainz — Mainz, Rhineland-Palatinate, Germany (enrolling)
• Universitätsklinikum C.-G.-Carus Dresden — Dresden, Saxony, Germany (enrolling)
• Charité Benjamin Franklin - Klinik für Hämatologie und Onkologie — Berlin, Germany (enrolling)
• Universitätsklinikum Hamburg-Eppendorf — Hamburg, Germany (enrolling)

Full record on ClinicalTrials.gov

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