Results From First-in-Human Phase I Study of a Novel CD19-1XX Chimeric Antigen Receptor With Calibrated Signaling in Large B-Cell Lymphoma.

ABSTRACT:

Purpose

We designed a CD19-targeted chimeric antigen receptor (CAR) comprising a calibrated signaling module, termed 1XX, that differs from that of conventional CD28/CD3ζ and 4-1BB/CD3ζ CARs. Preclinical data demonstrated that 1XX CARs generated potent effector function without undermining T-cell persistence. We hypothesized that 1XX CAR T cells may be effective at low doses and elicit minimal toxicities.

Methods

In this first-in-human, phase I, dose escalation and expansion clinical trial, patients with relapsed or refractory large B-cell lymphoma received 19(T2)28z-1XX CAR T cells at four dose levels (DLs), ranging from 25 to 200 × 10⁶.

Results

Twenty-eight patients underwent apheresis and received CAR T cells. Sixteen and 12 patients were treated in the

SUBMITTER: Park JH 

PROVIDER: S-EPMC12270773 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature