ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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 | Berlin | Germany | Recruiting |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | Germany | Recruiting |
On this site
📄 Opdivo (nivolumab) drug profile →More Immatics US, Inc. trials in the USA
Other trials for the same condition
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