Clinical trial · Observational
Dynamic Individualized Risk Profiling of Patients With Relapsed/Refractory Lymphoid Malignancies and CD19-CAR T Cell Therapy (INTeRCePT 2.0)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoid Hematological Malignancies | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- CAR T cell therapy-treated patients
- description
- Included are patients with relapsed/refractory lymphoid malignancies, treated with CD19-CAR T cell therapy.
Primary outcomes (1)
- measure
- Feasibilty of INTeRCePT assay
- timeFrame
- From enrollment until day28 post CAR T Infusion
- description
- 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).
Secondary outcomes (1)
- measure
- Rate of accurate prediction of complete response (CR vs. no CR) at month 3 post-CAR T infusion by the INTeRCePT assay
- timeFrame
- From enrollment until 3 months post CAR T cell infusion
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * 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 * Patients planned for CD19-redirected CAR T cell therapy according to clinical standard of care * Patients who are willing to donate peripheral blood and biopsy material at indicated clinical visits Exclusion 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
References
Publications (0)
Data not yet available