IMA203 Product: The cell dose will be based on viable CD3+CD8+ HLA- Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula
IMA203 product- flat dose: The cell dose will be based on viable CD3+CD8+ HLA- Dextramer+ cells
IMA203CD8 Product: The cell dose will be based on viable CD3+CD8+ HLA- Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula
Nivolumab: Nivolumab will be given post IMA203/IMA203CD8 infusion, after hematologic recovery is achieved. Clinical supply provided by Bristol Myers Squibb.
IMADetect®: IMADetect® is developed as a companion diagnostic to aid in selecting patients with relapsed and/or refractory solid cancers who might be eligible for enrollment in Immatics clinical trials.
Study summary
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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Phase 1: Determine the MTD and/or recommended dose for extension for IMA203/IMA203CD8 — 28 days Number of patients with dose-limiting toxicities (DLTs)
Phase 1 and Phase 2: Number and grade of treatment emergent adverse events and adverse events of special interest in subjects treated. — 35 days Treatment emergent adverse events (TEAEs), Adverse events of special interest (AESIs) and Treatment-emergent serious adverse events (TESAEs).
Phase 1 and Phase 2: Tumor Response — 5 years Objective response rate (ORR) based on best overall response (BOR) of complete response (CR) and partial response (PR) centrally assessed (by a BICR1) using RECIST1.1
Trial sites (21)
Facility
City
Region
Status
Stanford Cancer Institute
Stanford
California
Recruiting
University of Colorado, Anschutz Medical Campus
Aurora
Colorado
Recruiting
University of Miami Hospital and Clinics
Miami
Florida
Recruiting
University of Chicago Medical Center
Chicago
Illinois
Recruiting
Massachusetts General Hospital
Boston
Massachusetts
Recruiting
Memorial Sloan Kettering Cancer Center
New York
New York
Recruiting
Ohio State University Wexner Medical Center Gynecologic Oncology at Mill Run
Columbus
Ohio
Recruiting
University of Pennsylvania, Perelamn Center for Advanced Medicine
Philadelphia
Pennsylvania
Recruiting
Thomas Jefferson University, Honickman Center
Philadelphia
Pennsylvania
Recruiting
Fox Chase Cancer Center
Philadelphia
Pennsylvania
Recruiting
University of Pittsburgh Medical Center
Pittsburgh
Pennsylvania
Recruiting
University of Texas MD Anderson Cancer Center
Houston
Texas
Recruiting
Fred Hutchinson Cancer Center
Seattle
Washington
Recruiting
Universitätsklinikum Heidelberg, Nationales Centrum für Tumorerkrankungen (NCT)
Heidelberg
Baden-Wurttemberg
Recruiting
Klinikum rechts der Isar der Technischen Universität München
Munich
Bavaria
Recruiting
Universitätsklinikum Würzburg
Würzburg
Bavaria
Recruiting
Universitätsklinikum Bonn - Medizinische Klinik III
Bonn
North Rhine-Westphalia
Recruiting
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz
Rhineland-Palatinate
Recruiting
Universitätsklinikum C.-G.-Carus Dresden
Dresden
Saxony
Recruiting
Charité Benjamin Franklin - Klinik für Hämatologie und Onkologie
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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