drugset / Trial / NCT07869368

BLinatumomab and iNKT in Relapsed B-Cell ALL

NCT07869368 ↗

NaSingle-groupOpen-labelTreatment

Summary

This is an open-label, single-arm pilot study evaluating agenT-797, an invariant natural killer T-cell (iNKT) therapy, in combination with routine clinical care blinatumomab in subjects with Philadelphia chromosome-negative, CD19-positive B-cell acute lymphoblastic leukemia (B-ALL), who have experienced disease progression while receiving blinatumomab, become measurable residual disease (MRD)-positive following prior MRD negativity, or have relapsed disease. The primary objective of this study is to assess safety and tolerability of the first planned dose of agenT-797 in combination with blinatumomab. Secondary objectives include evaluating the efficacy of combination therapy and other predefined secondary endpoints. Up to 13 subjects will be enrolled in this study.

Timeline

Start
2026-10
Primary completion
2029-02
Completion
2030-02

Drugs

EvaluationDrugModalityDoseRoute
Subject agenT-797 Cell therapy — Intravenous