Study on ACTengine® IMA203/IMA203CD8 Alone or with Nivolumab for Treating Recurrent or Hard-to-Treat Solid Tumors
Sponsor: Immatics US, Inc.
ClinicalTrials ID:NCT03686124
This clinical trial is testing the safety and tolerability of a new treatment using IMA203/IMA203CD8, with or without the drug nivolumab, in patients with solid tumors that express a specific protein called PRAME.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to determine if the new treatments IMA203 and IMA203CD8, alone or combined with nivolumab, are safe and can be tolerated by patients with solid tumors that have returned or are difficult to treat. These tumors must express a protein known as PRAME.
Description
Screening: To see if you qualify for the study, doctors will check your health and perform tests, including a genetic test called HLA screening and a biopsy to look for specific markers in your tumor. If you qualify, your white blood cells will be collected to create the IMA203 or IMA203CD8 treatment.
Manufacturing: Your white blood cells will be used to make the IMA203 or IMA203CD8 treatment.
Treatment: Before receiving the IMA203/IMA203CD8 treatment, you will undergo a process called lymphodepletion using medications cyclophosphamide and fludarabine. This helps the treatment stay in your body longer. You will be admitted to the hospital for the infusion of the treatment.
After the infusion, you may receive a low dose of a medication called IL-2 under the skin until day 10. If you are in a specific group (Extension Cohort B), you will also receive nivolumab through an IV.
Throughout the study, you will be closely monitored. The follow-up phase will last for 5 years after the infusion.
Eligibility Criteria
Inclusion Criteria
- Have solid tumors that have returned or are hard to treat and have tried all standard treatments or are not eligible for them.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have a specific genetic marker called HLA-A*02:01.
- For ovarian/fallopian tube cancer patients: Must have a confirmed diagnosis of high-grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
- For endometrial carcinoma patients: Must have a confirmed diagnosis of recurrent or persistent endometrial carcinoma.
- Have measurable disease according to standard criteria.
- Have adequate organ function as determined by specific tests.
- Tumor must express a specific protein, confirmed by a test called IMADetect® RT-qPCR.
- Have a life expectancy of more than 5 months.
- Women of childbearing potential must use effective contraception before and for 12 months after treatment.
- Men must agree to use effective contraception or abstain from sex while on the study and for 6 months after treatment.
- Must have recovered from any side effects of previous treatments to a mild level before starting lymphodepletion.
Exclusion Criteria
- Have had another type of cancer within the last 3 years, except for certain skin cancers or carcinoma in situ.
- Be pregnant or breastfeeding.
- Have a serious autoimmune disease, unless well controlled without immunosuppressive drugs.
- Have a history of certain heart conditions.
- Have had a stem cell or organ transplant.
- Have severe or uncontrolled medical conditions that could affect participation.
- Have a history of or current immune system disorders or treatments that affect immune function.
- Test positive for HIV or have active hepatitis B or C infections.
- Have high levels of LDH in the blood.
- Have any condition that prevents leukapheresis, lymphodepletion, low-dose IL-2, or IMA203/IMA203CD8 treatment.
- Have active brain metastases.
- Be participating in another clinical trial.
- For nivolumab treatment, must not have had severe immune-related side effects from previous similar treatments.
Other criteria may apply.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Miami Hospital and Clinics | 33136 | Miami | Florida |
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
| Ohio State University Wexner Medical Center Gynecologic Oncology at Mill Run | 43026 | Columbus | Ohio |
| University of Pennsylvania, Perelamn Center for Advanced Medicine | 19104 | Philadelphia | Pennsylvania |
| Fox Chase Cancer Center | 19111 | Philadelphia | Pennsylvania |
| University of Pittsburgh Medical Center | 15232 | Pittsburgh | Pennsylvania |
| University of Texas MD Anderson Cancer Center | 77030 | Houston | Texas |
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