Cancer Clinical Trial
— ACTengineOfficial title:
Phase 1 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
The study 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).
Status | Recruiting |
Enrollment | 186 |
Est. completion date | December 2028 |
Est. primary completion date | December 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 phenotype positive for the study - Measurable disease according to RECIST 1.1 - Adequate selected organ function per protocol - Patient's tumor must express tumor antigen by "IMADetect® RT-qPCR - Life expectancy more than 3 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 2.5-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 |
Country | Name | City | State |
---|---|---|---|
Germany | Charité Benjamin Franklin - Klinik für Hämatologie und Onkologie | Berlin | |
Germany | Universitätsklinikum Bonn - Medizinische Klinik III | Bonn | North Rhine-Westphalia |
Germany | Universitätsklinikum C.-G.-Carus Dresden | Dresden | Saxony |
Germany | Universitätsklinikum Hamburg-Eppendorf | Hamburg | |
Germany | Universitätsklinikum Würzburg | Würzburg | Bavaria |
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
United States | University of Miami Hospital and Clinics | Miami | Florida |
United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Immatics US, Inc. |
United States, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate safety and tolerability of treatment with treatment with ACTengine® IMA203/IMA203CD8 products as monotherapy or in combination with nivolumab | Treatment emergent adverse events | 35 days | |
Primary | Determine the MTD and/or recommended dose for extension for IMA203/IMA203CD8 | Number of patients with dose-limiting toxicities (DLTs) | 28 days | |
Secondary | Persistence of T-cells | Measurement of TCR-engineered T cells in peripheral blood | up to 5 years post treatment | |
Secondary | Tumor response | Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 | up to 12 months | |
Secondary | Tumor response | Immune-Related Response Evaluation Criteria In Solid Tumors (irRECIST) | up to 12 months |
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