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Personalized cell therapy takes on advanced melanoma in major trial

NCT ID NCT06743126

Disease control Sponsor: Immatics US, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times

Summary

This Phase 3 trial tests a one-time cell therapy called IMA203 for people with advanced melanoma that has not responded to prior treatment. IMA203 is made from a patient's own immune cells and is designed to target cancer cells. The study compares IMA203 to standard treatments like nivolumab plus relatlimab or lifileucel. About 360 participants will be enrolled to see if IMA203 improves survival and tumor shrinkage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IMA203 (anzutresgene autoleucel), a personalized cell therapy made from the patient's own immune cells
What this could lead to
If successful, this could offer a new, one-time cell therapy option for people with advanced melanoma that has stopped responding to standard treatments.
What could go wrong
This is an early Phase 3 trial, so results are not guaranteed. Cell therapies can cause serious side effects, and the treatment may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 360 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Oct 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Pathologically confirmed and documented cutaneous melanoma- CM patients (including acral melanoma and melanoma of unknown primary) with unresectable or metastatic disease * HLA-A\*02:01 positive * Adequate selected organ function per protocol * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Disease progression (resistance, toxicity) on or after at least one PD-1 inhibitor, applied either as monotherapy or in combination with other therapies as treatment for unresectable or metastatic cutaneous melanoma * Patients with BRAF mutation should have been treated with one prior line of BRAF-directed therapy (with or without a MEK inhibitor) prior to initial eligibility assessment, unless deemed not clinically indicated at Investigator's discretion due to concurrent medical condition, prior toxicity, or if declined by the patient * Life expectancy more than 6 months * Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) * Female patient of childbearing potential must use adequate contraception from randomization until 12 months after the infusion of IMA203 or in line with the instructions provided for investigator's choice treatment (in the control arm) * Male patient must agree to use effective contraception or be abstinent while on study and for 6 months after the infusion of IMA203 or in line with the instructions provided for investigator's choice treatment (in the control arm) * The patient must have recovered from any side effects of prior therapy to Grade 1 or lower prior to randomization and prior to trial treatment start. Exclusion Criteria: * Primary mucosal or uveal melanoma * History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years * 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 allogenic 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 * History of hypersensitivity to CY, FLU, or IL-2 or presence of any contraindications and other limitations for planned treatment with investigator's choice as laid down in the current versions of the respective PIs / SmPCs * Known hypersensitivity to any of the rescue medications * History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the investigator * Positive for HIV infection or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection. * Any condition contraindicating leukapheresis * Pregnant or breastfeeding * Any other condition that would, in the investigator's or sponsor's judgment, contraindicate the patient's participation in the clinical trial because of safety concerns or compliance with clinical trial procedures (e.g., psychiatric disorders or substance dependence, neurological impairment) * Patient has received systemic corticosteroids within 2 weeks prior to leukapheresis, * Patient has received surgery or other anti-cancer therapies, any agent that is likely to suppress bone marrow function, or investigational medicinal products within 7 days prior to leukapheresis. * Patients with any active infection or ongoing reactivation of infection * Patients who underwent non-myeloablative lymphodepletion prior to cell therapy within the last 6 months * Prior treatment with IMA203 * Patients with ascites, pleural or pericardial effusion which requires repeated (2 within 4 weeks) or continuous paracentesis, thoracentesis or pericardiocentesis within last 2 months * Patients with LDH greater than 2.0-fold ULN * Concurrent treatment in another clinical trial or a device study that could interfere with the IMA203 treatment or planned investigator's choice treatment * Patients with active brain metastases or leptomeningeal metastases * Patient has received any investigational therapies, inactivated vaccines, chronic use of systemic corticosteroids or IV antibiotics within 1 week prior to randomization, or live vaccines within 4 weeks prior to randomization * Patient has received any anti-cancer therapy (prior anti-cancer treatment or bridging therapy) or radiotherapy within 1 week prior to start of trial treatment * Other protocol defined inclusion/exclusion criteria could apply

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Conditions

The condition(s) this trial relates to.

cutaneous melanoma Melanoma, Cutaneous Malignant melanoma, cutaneous malignant, susceptibility to, 1

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Melanoma, cutaneous malignant

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    71 sites in 6 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AdventHealth, Orlando

    NOT_YET_RECRUITING

    Orlando, Florida, 32804, United States

  • Assistance Publique Hopitaux De Paris, Hôpital Saint Louis

    RECRUITING

    Paris, 75010, France

  • Atlantic Health System/Morristown Medical Center

    RECRUITING

    Morristown, New Jersey, 07960, United States

  • Avera Cancer Institute

    RECRUITING

    Sioux Falls, South Dakota, 57105, United States

  • BC Cancer - Vancouver

    RECRUITING

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Baylor University

    RECRUITING

    Dallas, Texas, 75246, United States

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital

    RECRUITING

    Cambridge, CB2 0QQ, United Kingdom

  • Centre Hospitalier Universitaire De Lille

    RECRUITING

    Lille, 59000, France

  • Centre hospitalier de l'Université de Montréal (CHUM)

    RECRUITING

    Montreal, Quebec, H2X 0A9, Canada

  • Charite Universitaetsmedizin Berlin KöR

    RECRUITING

    Berlin, 12203, Germany

  • City of Hope National Medical Center

    RECRUITING

    Duarte, California, 91010, United States

  • Cleveland Clinic, Taussig Cancer Institute

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Cross Cancer Institute, Alberta

    RECRUITING

    Edmonton, Alberta, T6G 1Z2, Canada

  • Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

    RECRUITING

    Rotterdam, 3015 GD, Netherlands

  • Fox Chase Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19111, United States

  • Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Goethe University Frankfurt

    RECRUITING

    Frankfurt am Main, 60590, Germany

  • Greater Glasgow and Clyde NHS, Beatson West of Scotland Cancer Center

    RECRUITING

    Glasgow, G12 0YN, United Kingdom

  • Guy's and St Thomas' NHS Foundation Trust, Guy's Hospital

    RECRUITING

    London, SE1 9RT, United Kingdom

  • Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

    NOT_YET_RECRUITING

    Amsterdam, 1066 CX, Netherlands

  • Honor Health Research Institute

    RECRUITING

    Scottsdale, Arizona, 85258, United States

  • Huntsman Cancer Institute, University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, 94800, France

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • Lehigh Valley Topper Cancer Institute

    RECRUITING

    Allentown, Pennsylvania, 18103, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic Florida

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Oxford University Hospitals NHS Foundation Trust, Churchill Hospital

    RECRUITING

    Oxford, OX3 7LE, United Kingdom

  • Providence Cancer Institute Franz Clinic

    RECRUITING

    Portland, Oregon, 97213, United States

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Stanford Cancer Center

    RECRUITING

    Stanford, California, 94305, United States

  • Technische Universitaet Dresden

    RECRUITING

    Dresden, 01307, Germany

  • The Christie NHS Foundation Trust

    RECRUITING

    Manchester, M20 4GJ, United Kingdom

  • The Royal Marsden NHS Foundation Trust

    RECRUITING

    London, SW3 6JJ, United Kingdom

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Thomas Jeffersion University, Sidney Kimmel Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • UC San Diego Moores Cancer Center

    RECRUITING

    La Jolla, California, 92093, United States

  • UCLA Hematology/Oncology

    RECRUITING

    Los Angeles, California, 90024, United States

  • UCSF Helen Diller Family Comprehensive Cancer Center

    RECRUITING

    San Francisco, California, 94143, United States

  • UNC Hospitals, The University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • UPMC Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • Universitaet Leipzig

    RECRUITING

    Leipzig, 04103, Germany

  • Universitaetsklinikum Bonn AöR

    RECRUITING

    Bonn, 53127, Germany

  • Universitaetsklinikum Erlangen AöR

    RECRUITING

    Erlangen, 91054, Germany

  • Universitaetsklinikum Essen AöR

    RECRUITING

    Essen, 45147, Germany

  • Universitaetsklinikum Heidelberg AöR

    RECRUITING

    Heidelberg, 69120, Germany

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR

    RECRUITING

    Mainz, 55131, Germany

  • Universitair Medisch Centrum Groningen

    RECRUITING

    Groningen, 9713 GZ, Netherlands

  • Universitatsklinikum Koeln

    RECRUITING

    Cologne, Northrhine-W Estphalia, 50937, Germany

  • University Health Network, Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • University Medical Center Hamburg-Eppendorf

    RECRUITING

    Hamburg, 20246, Germany

  • University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Colorado, Anschutz Medical Campus

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of MD Greenebaum Comprehensive Cancer Center

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Miami - Sylvester Comprehensive Cancer Cente

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68198, United States

  • University of Pennsylvania, Abramson Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Rochester

    RECRUITING

    Rochester, New York, 14642, United States

  • University of Southampton NHS Foundation Trust, Southampton General Hospital

    NOT_YET_RECRUITING

    Southampton, SO16 6YD, United Kingdom

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of Wisconsin

    RECRUITING

    Madison, Wisconsin, 53792, United States

  • Virginia Commonwealth University

    RECRUITING

    Richmond, Virginia, 23219, United States

  • Winship Cancer Institute, Emory University

    NOT_YET_RECRUITING

    Atlanta, Georgia, 30322, United States

  • Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06510, United States

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