The INTeRCePT 2 study aims to develop a predictive assay to determine which patients with B cell lymphoma are most likely to respond to CAR T cell therapy. This assay combines five components for longitudinal profiling of each patient. The goal of the trial is that the assay can be completed (feasibility). This comprehensive assay integrates five key components including circulating tumor DNA (CAPPseq), inflammation markers from peripheral blood tests (InflaMIX), PET CT imaging parameters, immune cell profiles (flow cytometry), and performance status (ECOG). Ultimately, this tool could improve treatment selection, and guide more personalized therapy decisions for lymphoma patients receiving CAR T cells.
Written informed consent before registration and prior to any trial specific procedures
Participants ≥ 18 years of age
Diagnosis of relapse/refractory B-cell lymphoma according to WHO 2022 classification
Measurable disease per response criteria specific to the disease e.g. per Lugano 2014 criteria
Any condition, which precludes initiation of CD19-redirected CAR T cell therapy (e.g. breast feeding, pregnancy, infections, etc.) as judged by the treating physician
Any coexisting medical or psychological condition that would preclude participation in the required study procedures, as judged by the treating physician
Unwillingness or inability to comply with the protocol
The study population includes patients with lymphoid malignancies receiving anti-CD19 CAR T-cell therapy. This population is at high risk for disease progression. 50 patients in total will be enrolled in the study. The study does not include an additional control group but the risk analysis in arm B will be performed with blinding to the patient outcome. We expect to have a balanced sex proportion within our trial.
Cohort
Prospective
Not listed
Feasibilty of INTeRCePT assay
Risk profiling is performed by the INTeRCePT assay, which is a combinatorial, in-depth analysis of disease load (Liquid Biopsy, PET-CT/-MRI), immune environment "fitness" (scCytometry), performance status (ECOG) and inflammation status (InflaMix). The primary endpoint is the rate of successful completion of the INTeRCePT assay by day 38 post CAR T infusion (% of patients with complete INTeRCePT assay).
Rate of accurate prediction of complete response (CR vs. no CR) at month 3 post-CAR T infusion by the INTeRCePT assay
The key secondary endpoint will be the rate of accurate prediction of complete response (CR vs. no CR) by 3 months post-CAR T-cell infusion (% of correctly predicted patient outcomes). CR is defined as complete remission 3 months post CAR T cell therapy without the need for additional cancer-directed treatment.
Rate of sensitivity and specificity by the INTeRCePT assay and its components
Prediction of complete response (CR vs. no CR) and overall response rate (ORR, CR/PR vs. no CR/PR) by INTeRCePT assay and its components at month 1, 2, 3, 6, and 12
Prediction of progression free survival (PFS) and overall survival (OS) by INTeRCePT assay and its components
Prediction of duration of response (DOR) by INTeRCePT assay and its response
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