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RECRUITING
NCT03686124
PHASE1/PHASE2

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

Sponsor: Immatics US, Inc.

View on ClinicalTrials.gov

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).

Official title: Phase 1/2 Study Evaluating Genetically Modified Autologous T Cells Expressing a TCR Recognizing a Cancer/Germline Antigen as Monotherapy or in Combination With Nivolumab in Patients With Recurrent and/or Refractory Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

375

Start Date

2019-05-14

Completion Date

2032-06

Last Updated

2026-03-27

Healthy Volunteers

No

Interventions

BIOLOGICAL

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

BIOLOGICAL

IMA203 product- flat dose

The cell dose will be based on viable CD3+CD8+ HLA- Dextramer+ cells

BIOLOGICAL

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

DRUG

Nivolumab

Nivolumab will be given post IMA203/IMA203CD8 infusion, after hematologic recovery is achieved. Clinical supply provided by Bristol Myers Squibb.

DEVICE

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.

Locations (19)

Stanford Cancer Institute

Stanford, California, United States

University of Miami Hospital and Clinics

Miami, Florida, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Ohio State University Wexner Medical Center Gynecologic Oncology at Mill Run

Columbus, Ohio, United States

University of Pennsylvania, Perelamn Center for Advanced Medicine

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Universitätsklinikum Heidelberg, Nationales Centrum für Tumorerkrankungen (NCT)

Heidelberg, Baden-Wurttemberg, Germany

Klinikum rechts der Isar der Technischen Universität München

Munich, Bavaria, Germany

Klinikum rechts der Isar der Technischen Universität München

Munich, Bavaria, Germany

Universitätsklinikum Würzburg

Würzburg, Bavaria, Germany

Universitätsklinikum Bonn - Medizinische Klinik III

Bonn, North Rhine-Westphalia, Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, Rhineland-Palatinate, Germany

Universitätsklinikum C.-G.-Carus Dresden

Dresden, Saxony, Germany

Charité Benjamin Franklin - Klinik für Hämatologie und Onkologie

Berlin, Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany