NCT03686124 ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors
| NCT ID | NCT03686124 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Immatics US, Inc. |
| Condition | Refractory Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 375 participants |
| Start Date | 2019-05-14 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 375 participants in total. It began in 2019-05-14 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
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
Contact & Investigator
Cedrik Britten, M.D.
STUDY DIRECTOR
Immatics US, Inc.
Frequently Asked Questions
Who can join the NCT03686124 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Refractory Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03686124 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03686124 currently recruiting?
Yes, NCT03686124 is actively recruiting participants. Contact the research team at ctgovinquiries@immatics.com for enrollment information.
Where is the NCT03686124 trial being conducted?
This trial is being conducted at Stanford, United States, Aurora, United States, Miami, United States, Chicago, United States and 11 additional locations.
Who is sponsoring the NCT03686124 clinical trial?
NCT03686124 is sponsored by Immatics US, Inc.. The principal investigator is Cedrik Britten, M.D. at Immatics US, Inc.. The trial plans to enroll 375 participants.
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