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Engineered T-Cells take on recurrent solid tumors in new trial

NCT ID NCT03686124

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new treatment for people with solid tumors that have come back or not responded to standard care. The treatment uses a patient's own immune cells (T-cells) that are genetically modified in a lab to recognize and attack a protein called PRAME found on cancer cells. Some participants will also receive the drug nivolumab (Opdivo) to boost the immune response. The trial aims to find the safest dose and see if the treatment can shrink tumors.

What this could mean

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

Active substance
Genetically modified immune cells (T-cells) designed to target PRAME protein, sometimes combined with nivolumab (Opdivo)
What this could lead to
If successful, this could offer a new treatment option for people with hard-to-treat solid tumors that have stopped responding to standard therapies.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants, so the treatment may not work for many people. There are also risks of serious side effects from the cell therapy and the combination with nivolumab.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 375 people

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

Started

May 2019

Expected to finish

Jun 2032

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: * 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

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Conditions

The condition(s) this trial relates to.

cancer endometrial carcinoma fallopian tube cancer melanoma neoplasm ovarian cancer Recurrence refractory malignant neoplasm Uveal Melanoma

As listed by the trial registrant

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

Cancer Recurrent cancer Refractory cancer Solid tumor, adult

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

    21 sites in 2 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

  • Charité Benjamin Franklin - Klinik für Hämatologie und Onkologie

    RECRUITING

    Berlin, 12203, Germany

  • Fox Chase Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19111, United States

  • Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Klinikum rechts der Isar der Technischen Universität München

    RECRUITING

    Munich, Bavaria, 81675, Germany

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Ohio State University Wexner Medical Center Gynecologic Oncology at Mill Run

    RECRUITING

    Columbus, Ohio, 43026, United States

  • Stanford Cancer Institute

    RECRUITING

    Stanford, California, 94305, United States

  • Thomas Jefferson University, Honickman Center

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • 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 Miami Hospital and Clinics

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Pennsylvania, Perelamn Center for Advanced Medicine

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Universitätsklinikum Bonn - Medizinische Klinik III

    RECRUITING

    Bonn, North Rhine-Westphalia, 53127, Germany

  • Universitätsklinikum C.-G.-Carus Dresden

    RECRUITING

    Dresden, Saxony, 01307, Germany

  • Universitätsklinikum Hamburg-Eppendorf

    RECRUITING

    Hamburg, 20246, Germany

  • Universitätsklinikum Heidelberg, Nationales Centrum für Tumorerkrankungen (NCT)

    RECRUITING

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • Universitätsklinikum Würzburg

    RECRUITING

    Würzburg, Bavaria, 97080, Germany

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    RECRUITING

    Mainz, Rhineland-Palatinate, 55131, Germany

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