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

NCT07472972 | Recruiting DMC

• 2 other identifiers: INTeRCePT2.0BASEC-Nr. 2024-02540
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Lymphoma; Lymphoid Hematological Malignancies

Keywords

CAR T cell therapy; Anti-CD19; Anti-CD19 CAR T cell therapy; lymphoid malignancies; CD19-CAR T cell therapy; INTeRCePT 2.0; risk profiling; relapsed/refractory

Outcome Measures

Primary Outcomes (1)

• 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).

  From enrollment until day28 post CAR T Infusion

Secondary Outcomes (1)

• Rate of accurate prediction of complete response (CR vs. no CR) at month 3 post-CAR T infusion by the INTeRCePT assay

  From enrollment until 3 months post CAR T cell infusion

Other Outcomes (8)

• Rate of sensitivity and specificity by the INTeRCePT assay and its components

  Enrollment until 12 months post CAR T Infusion

• 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

  Enrollment until 12 months post CAR T Infusion

• Prediction of progression free survival (PFS) and overall survival (OS) by INTeRCePT assay and its components

  Enrollment until 2 years post CAR T Infusion

Study Arms (1)

CAR T cell therapy-treated patients

Included are patients with relapsed/refractory lymphoid malignancies, treated with CD19-CAR T cell therapy.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• University Hospital, Zürich: collaborator
• Clinical Trials Center of the UniversityHospital Zurich: collaborator
• ETH Zurich: collaborator

Study Sites (1)

Universityhospital Zurich, Department of Medical Oncology and Hematology

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

* blood * stool If available through standard-of-care procedures: * biopsy samples (e.g. bone marrow, lymphoid tissue) * PBMCs * CAR T cells * Granulocytes * plasma

MeSH Terms

Conditions

Lymphoma; Recurrence

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Thorsten Zenz, Prof. Dr. med.

CONTACT

+41 44 255 38 99; thorsten.zenz@usz.ch

Stefanie Kreutmair, Dr. med.

CONTACT

+41 44 255 11 11

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: March 16, 2026
• Study Start: June 20, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): May 31, 2030
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

CH (1)