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ACTengine® IMA203/IMA203CD8 for Recurrent/Refractory Solid Tumors

This study is testing the safety and effectiveness of treatments called IMA203 and IMA203CD8, either alone or with nivolumab (an immunotherapy drug), for adults with solid tumors that have returned or are not responding to standard treatments. You might be eligible if you have certain types of solid tumors, have an ECOG performance status of 0-1 (meaning you are fully active or can carry out light work), and are HLA-A*02:01 positive (a specific genetic marker). The study aims to find the best dose and see how well these treatments shrink tumors over five years. Your white blood cells will be used to create the IMA203 or IMA203CD8 products.

Study design
This is an interventional study with a planned enrollment of 375 participants. It is designed to determine the maximum tolerated dose and evaluate tumor response.
What's involved
You will undergo screening, including HLA testing and a biopsy. White blood cells will be collected, and you will receive lymphodepletion before the IMA203/IMA203CD8 infusion, which requires hospitalization. You may also receive IL-2 and/or nivolumab.
Compensation
Not stated in the trial record.
Follow-up
You will be monitored closely throughout the study, with a follow-up phase lasting up to 5 years after the infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03686124

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Immatics US, Inc.
~375 participants
Updated 2026-05-13 on ClinicalTrials.gov
What's tested:IMA203 ProductIMA203 product- flat doseIMA203CD8 ProductNivolumabIMADetect®

At a glance

Recruiting sites
21 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1: Determine the MTD and/or recommended dose for extension for IMA203/IMA203CD8
Measured over 28 days
+2 more outcomes measured

Conditions

Refractory Cancer
Recurrent Cancer
Solid Tumor, Adult
Cancer

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Endometrial CarcinomaMalignant Ovarian NeoplasmMelanomaSolid NeoplasmHLA Class I Histocompatibility Antigen, A-0201 Alpha ChainPRAME Gene

Where it's being run

21 sites across 16 states
Pennsylvania4
Bavaria2
Germany2
California1
Colorado1
Florida1
Illinois1
Massachusetts1

Study leadership

  • Cedrik Britten, M.D. · STUDY_DIRECTOR · Immatics US, Inc.

Who to contact

Immatics US, Inc.
[email protected]
+1 346 204-5400
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.).

What this trial measures

  • Phase 1: Determine the MTD and/or recommended dose for extension for IMA203/IMA203CD828 days

    Number of patients with dose-limiting toxicities (DLTs)

  • Phase 1 and Phase 2: Number and grade of treatment emergent adverse events and adverse events of special interest in subjects treated.35 days

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

  • Phase 1 and Phase 2: Tumor Response5 years

    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