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

RecruitingPhase 1/2

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the study

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).

What is being tested

Sponsor: Immatics US, Inc. · Participants: 375 · Started: May 14, 2019

Contact the study team

Official record on ClinicalTrials.gov — NCT03686124

Locations in the U.S.

CaliforniaStanford Cancer Institute, Stanford
ColoradoUniversity of Colorado, Anschutz Medical Campus, Aurora
FloridaUniversity of Miami Hospital and Clinics, Miami
IllinoisUniversity of Chicago Medical Center, Chicago
MassachusettsMassachusetts General Hospital, Boston
New YorkMemorial Sloan Kettering Cancer Center, New York
OhioOhio State University Wexner Medical Center Gynecologic Oncology at Mill Run, Columbus
PennsylvaniaFox Chase Cancer Center, Philadelphia
Thomas Jefferson University, Honickman Center, Philadelphia
University of Pennsylvania, Perelamn Center for Advanced Medicine, Philadelphia
University of Pittsburgh Medical Center, Pittsburgh
TexasUniversity of Texas MD Anderson Cancer Center, Houston
WashingtonFred Hutchinson Cancer Center, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.