RecruitingPhase 1Phase 2NCT03686124

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

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

Sponsor

Immatics US, Inc.

Enrollment

375 participants

Start Date

May 14, 2019

Study Type

INTERVENTIONAL

Conditions

Cancer Solid Tumor, Adult Refractory Cancer Recurrent Cancer

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new type of personalized cell therapy — where a patient's own immune cells (T cells) are genetically modified to recognize and attack a specific protein found on many solid tumors — either alone or combined with nivolumab, in people with advanced solid tumors that have stopped responding to other treatments. **You may be eligible if...** - You have an advanced solid tumor (such as ovarian, endometrial, or other cancers) that has come back or stopped responding to all available standard treatments - Your immune cells match a specific genetic marker (HLA-A*02:01 positive) - Your tumor expresses a specific protein target that can be detected by a special test - You are well enough to carry out daily activities (ECOG 0–1) - Your life expectancy is more than 5 months **You may NOT be eligible if...** - You have had a previous stem cell or organ transplant - You are pregnant or breastfeeding - You have a serious autoimmune disease that is not well controlled - You have significant heart problems - You have an active uncontrolled infection or serious medical illness - You have had another cancer in the past 3 years (with some exceptions) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALIMA203 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

BIOLOGICALIMA203 product- flat dose

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

BIOLOGICALIMA203CD8 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

DRUGNivolumab

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

DEVICEIMADetect®

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(21)

Stanford Cancer Institute

Stanford, California, United States

University of Colorado, Anschutz Medical Campus

Aurora, Colorado, 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

Thomas Jefferson University, Honickman Center

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

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Universitätsklinikum Heidelberg, Nationales Centrum für Tumorerkrankungen (NCT)

Heidelberg, Baden-Wurttemberg, 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

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NCT03686124

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