Actively Recruiting
ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors
Led by Immatics US, Inc. · Updated on 2026-05-13
375
Participants Needed
21
Research Sites
681 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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 unless well controlled without 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
- History of or current immunodeficiency disease or prior treatment compromising immune function
- Positive for HIV infection or with active hepatitis B or C 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
- History of severe immune-related toxicities from prior PD1/PD-L1 inhibitor therapy
- Other protocol defined inclusion/exclusion criteria could apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
Stanford Cancer Institute
Stanford, California, United States, 94305
Actively Recruiting
2
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
3
University of Miami Hospital and Clinics
Miami, Florida, United States, 33136
Actively Recruiting
4
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
5
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
7
Ohio State University Wexner Medical Center Gynecologic Oncology at Mill Run
Columbus, Ohio, United States, 43026
Actively Recruiting
8
University of Pennsylvania, Perelamn Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
9
Thomas Jefferson University, Honickman Center
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
10
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
11
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
12
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
13
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
14
Universitätsklinikum Heidelberg, Nationales Centrum für Tumorerkrankungen (NCT)
Heidelberg, Baden-Wurttemberg, Germany, 69120
Actively Recruiting
15
Klinikum rechts der Isar der Technischen Universität München
Munich, Bavaria, Germany, 81675
Actively Recruiting
16
Universitätsklinikum Würzburg
Würzburg, Bavaria, Germany, 97080
Actively Recruiting
17
Universitätsklinikum Bonn - Medizinische Klinik III
Bonn, North Rhine-Westphalia, Germany, 53127
Actively Recruiting
18
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Rhineland-Palatinate, Germany, 55131
Actively Recruiting
19
Universitätsklinikum C.-G.-Carus Dresden
Dresden, Saxony, Germany, 01307
Actively Recruiting
20
Charité Benjamin Franklin - Klinik für Hämatologie und Onkologie
Berlin, Germany, 12203
Actively Recruiting
21
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
Research Team
I
Immatics US, Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
12
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