No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
375 (estimated)
Sponsor
Immatics US, Inc. · Industry
Who this trial is looking for
This trial is looking for patients with certain types of cancer that keep coming back or do not respond to standard treatments. Participants will receive the study treatment IMA203/IMA203CD8, either alone or with nivolumab.
Are You a Good Fit for This Trial?
You may be able to join if
I have recurrent or progressing solid tumors.
I have measurable disease.
I have recovered from any side effects of previous therapy.
I have an HLA-A*02:01 positive test.
My life expectancy is more than 5 months.
I am a female of childbearing potential using contraception.
I am a male agreeing to use effective contraception.
You may not be able to join if
I am pregnant or breastfeeding.
I have a serious autoimmune disease.
I have a history of cardiac conditions.
I have HIV or active hepatitis B or C.
I have had a stem cell or solid organ transplantation.
I have active brain metastases.
I have had severe reactions to PD1/PD-L1 inhibitor therapy.
I have a significant medical disease that could affect the study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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).
Trial Locations
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City
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Status
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 w…
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.).
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