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NOT YET RECRUITING
NCT07869368
PHASE1

BLinatumomab and iNKT in Relapsed B-Cell ALL

Sponsor: UNC Lineberger Comprehensive Cancer Center

View on ClinicalTrials.gov

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.

Official title: BLINKB-ALL: BLinatumomab and iNKT in Relapsed B-Cell ALL

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

13

Start Date

2026-10

Completion Date

2030-02

Last Updated

2026-10-09

Healthy Volunteers

No

Interventions

BIOLOGICAL

Invariant Natural Killer T Cell Therapy

AgenT-797 is an investigational invariant natural killer T (iNKT) cell therapy administered as a single intravenous infusion in combination with blinatumomab.

Locations (1)

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States