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New treatment option for Refractory Cancer
Official title ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors
ClinicalTrials.gov ID: NCT03686124
What this study is testing
What is IMA203 Product?
IMA203 Product is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for refractory cancer.
Also referred to as anzutresgene autoleucel, anzu-cel.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have recurrent/progressing and/or refractory solid tumors and must have received or not be eligible for all available indicated...
- 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...
- For patients with endometrial carcinoma only: Patients must have a histologically confirmed diagnosis of recurrent or persistent endometrial...
You likely can't join if
- 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...
- 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
See the full eligibility 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Stanford, California, United States
- Aurora, Colorado, United States
- Miami, Florida, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Heidelberg, Baden-Wurttemberg, Germany
- Munich, Bavaria, Germany
- Würzburg, Bavaria, Germany
- Bonn, North Rhine-Westphalia, Germany
- Mainz, Rhineland-Palatinate, Germany
- Dresden, Saxony, Germany
- Berlin, Germany
- Hamburg, Germany
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stanford, California, United States; Aurora, Colorado, United States; Miami, Florida, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States; New York, New York, United States and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.