drugset / Trial / NCT03843294

Tumor Associated Antigen Specific T Cells (TAA-T) With PD1 Inhibitor for Lymphoma

NCT03843294 ↗

Phase 1 Active not recruiting 18 enrolled Catherine Bollard
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase I, open-label multi-site trial designed to evaluate the safety of administering rapidly-generated Tumor associated antigen specific T cells (TAA-T) with the Programmed Death1 (PD-1) inhibitor Nivolumab, in relapsed/refractory lymphoma (rel/ref) patients with measurable disease (group A) or as adjunctive therapy following autologous hematopoeitic stem cell transplant(HSCT) for patients at high risk of relapse (group B). The purpose of this study is to find out if the tumor specific T cells given with Nivolumab are safe and to learn what the side effects are and if the combination can help patients with relapsed lymphomas.

Timeline

Start
2019-06-24
Primary completion
2023-05-02
Completion
2026-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Nivolumab Monoclonal antibody 1 mg/kg —
Subject Nivolumab Monoclonal antibody 3 mg/kg —
Subject Nivolumab Monoclonal antibody 100 mg —
Subject Nivolumab Monoclonal antibody 200 mg —
Subject Nivolumab Monoclonal antibody 240 mg —
Subject Nivolumab Monoclonal antibody 480 mg —
Subject TAA-T cells Unknown 1e+07 unknown —
Subject TAA-T cells Unknown 2e+07 unknown —