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Refractory CancerPhase 1/2ACTengineNCT03686124

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

A Phase 1/2 study testing IMA203 Product, IMA203 product- flat dose and IMA203CD8 Product in people with Refractory Cancer and Recurrent Cancer, run by Immatics US, Inc. at 21 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
IMA203 Product, IMA203 product- flat dose and IMA203CD8 Product
Could I receive a placebo?
No, everyone receives an active treatment
How many people
375 participants
Where
21 sitesin 2 countries
Study dates
14 May 2019to Jun 2032
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

21 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Immatics US, Inc. contact

+1 346 204-5400

ctgovinquiries@immatics.com

21 sites in 2 countries

United States13 sites, 13 recruiting

  • University of Colorado, Anschutz Medical Campus

    Aurora, Colorado, 80045

    Sapna Patel, MD, 720-848-0000

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Oldadapo O. Yeku, MD. PhD, 617-643-6158

    Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

    Katherine Kurnit, MD

    Recruiting

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

    Columbus, Ohio, 43026

    Casey Cosgrove, MD, Casey.Cosgrove@osumc.edu

    Recruiting

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Dejka M Araujo, M.D., 713-792-3626, daraujo@mdanderson.org

    Dejka M Araujo, M.D.

    Recruiting

  • University of Miami Hospital and Clinics

    Miami, Florida, 33136

    305-243-2647, CRSCutaneous@miami.edu

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Alexander Shoushtari, MD, 646-888-4161, shoushta@mskcc.org

    Recruiting

  • University of Pennsylvania, Perelamn Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19104

    Janos Tanyi, MD, PhD, Janos.Tanyi@pennmedicine.upenn.edu

    Recruiting

  • Thomas Jefferson University, Honickman Center

    Philadelphia, Pennsylvania, 19107

    Rino Seedor, MD, 215-847-7409, Rino.Seedor@jefferson.edu

    Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Anthony Olszanski, MD, RPh, Anthony.Olszanski@fccc.edu

    Anthony Olszanski, MD

    Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

    Diwakar Davar, M.D., 412-623-7368, davard@upmc.edu

    Jason Luke, M.D.

    Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Sylvia Lee, MD, leesm@uw.edu

    Recruiting

  • Stanford Cancer Institute

    Stanford, California, 94305

    Allison Warner, MD, allison.betof@stanford.edu

    Recruiting

Other trials in United States

Germany8 sites, 8 recruiting

  • Charité Benjamin Franklin - Klinik für Hämatologie und Onkologie

    Berlin, 12203

    Recruiting

  • Universitätsklinikum Bonn - Medizinische Klinik III

    Bonn, North Rhine-Westphalia, 53127

    Recruiting

  • Universitätsklinikum C.-G.-Carus Dresden

    Dresden, Saxony, 01307

    Recruiting

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

    Recruiting

  • Universitätsklinikum Heidelberg, Nationales Centrum für Tumorerkrankungen (NCT)

    Heidelberg, Baden-Wurttemberg, 69120

    Recruiting

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, Rhineland-Palatinate, 55131

    Recruiting

  • Klinikum rechts der Isar der Technischen Universität München

    Munich, Bavaria, 81675

    Recruiting

  • Universitätsklinikum Würzburg

    Würzburg, Bavaria, 97080

    Recruiting

Other trials in Germany

About this study

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

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).

Read the detailed description

SCREENING: Patient eligibility will be determined by protocol inclusion/exclusion criteria including HLA (human leukocyte antigen) screening and a biopsy (or collection of archival tumor tissue) for biomarker screening. If the patient is eligible, white blood cells will be taken during leukapheresis for the manufacture of IMA203 or IMA203CD8 product.

MANUFACTURING: IMA203 or IMA203CD8 products will be made from the patients' white blood cells.

TREATMENT: Lymphodepletion with cyclophosphamide and fludarabine will occur in the days before the IMA203/IMA203CD8 product infusion to improve the duration of time that IMA203/IMA203CD8 product stays in the body. The patient will be admitted to the hospital during the T-cell infusion.

After the IMA203/IMA203CD8 product infusion, if applicable, a low dose of IL-2 will be given subcutaneously until day 10.

In Extension Cohort B (IMA203) nivolumab will be administered intravenously.

Patients will be monitored closely throughout the study. The follow-up phase ends 5 years post infusion.

Being tested
IMA203 Product, IMA203 product- flat dose, IMA203CD8 Product, Nivolumab, IMADetect®
Keywords
T-cell therapy, immunotherapy, Melanoma (Skin), Melanoma, Uveal, Ovarian Carcinoma, Uterine Carcinoma, Uterine Carcinosarcoma, Immatics
Medical subject headings
Neoplasms, Recurrence, Melanoma, Uveal Melanoma, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMA203 ProductBiological

    Also called anzutresgene autoleucel, anzu-cel

    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 doseBiological

    Also called anzutresgene autoleucel, anzu-cel

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

  • IMA203CD8 ProductBiological

    The cell dose will be based on viable CD3+CD8+ HLA- Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula

  • NivolumabDrug

    Also called Opdivo®

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

  • IMADetect®Device

    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 groups in NCT03686124
Study groupRoleWhat they receive
Dose Escalation A (closed to enrollment)ExperimentalDose escalation of IMA203
Receives: Biological: IMA203 Product; Device: IMADetect®
Extension Cohort AExperimentalIMA203 at RP2D
Receives: Biological: IMA203 Product; Device: IMADetect®
Extension Cohort B (closed to enrollment)ExperimentalIMA203 at RP2D + nivolumab
Receives: Biological: IMA203 Product; Drug: Nivolumab
Extension Cohort AAExperimentalIMA203 at final RP2D (flat dose)
Receives: Biological: IMA203 product- flat dose; Device: IMADetect®
Uveal MelanomaExperimentalIMA203 at RP2D
Receives: Biological: IMA203 Product; Device: IMADetect®
Dose Escalation BExperimentalDose escalation of IMA203CD8
Receives: Biological: IMA203CD8 Product; Device: IMADetect®
Extension Cohort CExperimentalIMA203CD8 at dose levels confirmed to be safe
Receives: Biological: IMA203CD8 Product; Device: IMADetect®
Extension Cohort DExperimentalIMA203CD8 at dose levels confirmed to be safe; without IL-2
Receives: Biological: IMA203CD8 Product; Device: IMADetect®
OvarianExperimentalIMA203CD8 monotherapy at dose levels confirmed to be safe
Receives: Biological: IMA203CD8 Product; Device: IMADetect®
EndometrialExperimentalIMA203CD8 monotherapy at dose levels confirmed to be safe
Receives: Biological: IMA203CD8 Product; Device: IMADetect®
Head and Neck, Lung, and Triple Negative Breast CancerExperimentalIMA203CD8 monotherapy at dose levels confirmed to be safe
Receives: Biological: IMA203CD8 Product; Device: IMADetect®
Rare CancersExperimentalIMA203CD8 monotherapy at dose levels confirmed to be safe
Receives: Biological: IMA203CD8 Product; Device: IMADetect®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1: Determine the MTD and/or recommended dose for extension for IMA203/IMA203CD8

    Number of patients with dose-limiting toxicities (DLTs)

    Measured: 28 days

  2. Phase 1 and Phase 2: Number and grade of treatment emergent adverse events and adverse events of special interest in subjects treated.

    Treatment emergent adverse events (TEAEs), Adverse events of special interest (AESIs) and Treatment-emergent serious adverse events (TESAEs).

    Measured: 35 days

  3. Phase 1 and Phase 2: Tumor Response

    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

    Measured: 5 years

Secondary outcomes (3)

  1. Phase 1 and 2: Persistence of TCR engineered T-cells

    Measurement of TCR-engineered T cells in peripheral blood

    Measured: up to 5 years post treatment

  2. Phase 1 and 2: Tumor response

    Overall response rate, duration of response, disease control rate and progression free survival based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Overall survival.

    Measured: up to 5 years

  3. Phase 2: Patient reported quality of life

    Quality of Life questionnaires (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and EuroQol 5-Dimension 5-Level questionnaire). Higher score indicates worsening of patient's condition.

    Measured: up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2018
  2. Study start14 May 2019
  3. Primary completionDec 2028 (estimated)
  4. Study completionJun 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
375 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03686124
Sponsor's protocol ID
IMA203-101
Acronym
ACTengine
Status last verified
May 2026
First submitted
25 Sep 2018
Last updated
13 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes

Publications

  • Wermke M, Araujo DM, Chatterjee M, Tsimberidou AM, Holderried TAW, Jazaeri AA, Reshef R, Bokemeyer C, Alsdorf W, Wetzko K, Brossart P, Aslan K, Backert L, Bunk S, Fritsche J, Gulde S, Hengler S, Hilf N, Hossain MB, Hukelmann J, Kalra M, Krishna D, Kursunel MA, Maurer D, Mayer-Mokler A, Mendrzyk R, Mohamed A, Pozo K, Satelli A, Letizia M, Schuster H, Schoor O, Wagner C, Rammensee HG, Reinhardt C, Singh-Jasuja H, Walter S, Weinschenk T, Luke JJ, Britten CM. Autologous T cell therapy for PRAME+ advanced solid tumors in HLA-A*02+ patients: a phase 1 trial. Nat Med. 2025 Jul;31(7):2365-2374. doi: 10.1038/s41591-025-03650-6. Epub 2025 Apr 9.

    PubMed 40205198

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IMA203 Product, IMA203 product- flat dose and IMA203CD8 Product in people with Refractory Cancer and Recurrent Cancer, run by Immatics US, Inc. at 21 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Immatics US, Inc. (+1 346 204-5400, ctgovinquiries@immatics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Determine the MTD and/or recommended dose for extension for IMA203/IMA203CD8 (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03686124, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.

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