Dynamic individualized risk profiling for patients receiving CD19 CAR T-cell therapy

Dynamic Individualized Risk Profiling of Patients With Relapsed/Refractory Lymphoid Malignancies and CD19-CAR T Cell Therapy (INTeRCePT 2.0)

This project tries a combined blood, imaging, and lab test to predict which adults with relapsed or refractory B‑cell lymphoma will do well after CD19 CAR T‑cell therapy.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Sex: All
• Sponsor: University of Zurich (other)
• Drugs / interventions: CAR T, CAR-T
• Locations: 1 site (Zurich, Canton of Zurich)
• Trial ID: NCT07472972 on ClinicalTrials.gov

What this trial studies

INTeRCePT 2.0 is a prospective observational feasibility study enrolling adults with relapsed or refractory B‑cell lymphomas who are scheduled to receive standard‑of‑care CD19‑redirected CAR T‑cell therapy. The study collects serial data across five components—circulating tumor DNA by CAPP‑seq, peripheral blood inflammation markers (InflaMIX), PET‑CT imaging metrics, immune cell profiling by flow cytometry, and ECOG performance status—to build a dynamic individualized risk profile for each patient. The primary objective is feasibility, measured as the rate of complete INTeRCePT assay profiling with a co‑primary endpoint of completing the profile by 38 days after CAR T infusion. If feasible, the longitudinal assay is intended to enable earlier detection of high‑risk patients to guide more personalized treatment decisions in future interventional work.

Who should consider this trial

Good fit: Adults (≥18) with relapsed or refractory B‑cell lymphoma who are planned for CD19‑redirected CAR T‑cell therapy and willing to provide serial blood samples and biopsy material are ideal candidates.

Not a fit: Patients not receiving CD19 CAR T therapy, those with contraindications to CAR T infusion, or those unable or unwilling to complete the required serial sampling and visits are unlikely to benefit from this assay.

Why it matters

Potential benefit: If successful, the assay could identify patients at high risk of early CAR T failure so clinicians can consider earlier or intensified treatment strategies.

How similar studies have performed: Individual components such as ctDNA and PET imaging have shown promise in predicting CAR T outcomes in prior work, but the integrated five‑component longitudinal INTeRCePT assay is novel and remains unproven.

Eligibility criteria

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

Where this trial is running

Zurich, Canton of Zurich

• Universityhospital Zurich, Department of Medical Oncology and Hematology — Zurich, Canton of Zurich, Switzerland (RECRUITING)

Study contacts

• Study coordinator: Thorsten Zenz, Prof. Dr. med.

Conditions: Lymphoma, Lymphoid Hematological Malignancies, CAR T cell therapy, Anti-CD19, Anti-CD19 CAR T cell therapy, lymphoid malignancies, CD19-CAR T cell therapy, INTeRCePT 2.0