Ireland
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Recruiting Phase 1/2

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

NCT03686124 · tracked via the Priya Life Science USA tracker
Phase
Phase 1/2
Started
2019-05-14
Last updated
2026-05-13

Condition(s) studied

Refractory CancerRecurrent CancerSolid Tumor, AdultCancer

Investigational drug(s) / intervention(s)

IMA203 Product →IMA203 product- flat dose →IMA203CD8 ProductNivolumab →IMADetect®

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)

FacilityCityRegionStatus
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 Berlin Germany Recruiting
Universitätsklinikum Hamburg-Eppendorf Hamburg Germany Recruiting
Official registry record

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.

View NCT03686124 on ClinicalTrials.gov ↗ ← All trials in the USA