Natural killer T cell therapy plus blinatumomab for relapsed B-cell acute lymphoblastic leukemia
Tests agenT-797 cells with blinatumomab in adults whose B-cell leukemia returned or progressed.
Plain-language title generated from the registry record
Registry title: BLinatumomab and iNKT in Relapsed B-Cell ALL
Key facts
- Where
- Chapel Hill, United StatesSee the site
- Phase
- Phase 1
Where in United States
- UNC Lineberger Comprehensive Cancer CenterChapel Hill, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- UNC Lineberger Comprehensive Cancer Center
- Trial code
- NCT07869368
- Record updated
- 5 November 2026
- Original description
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.Read full original descriptionShow less
BLINKB-ALL: BLinatumomab and iNKT in Relapsed B-Cell ALL
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.
Inclusion: Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information; Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee; Age ≥ 18 years; Diagnosis of B-cell ALL; Detection of new MRD positivity after prior MRD negativity, or frank relapse while receiving or after blinatumomab. MRD positivity will be assessed by multiparameter flow.
Exclusion: Other concurrent leukemia-directed therapy; Participants with active CNS 3 disease (central nervous system leukemia involvement); Uncontrolled infection; Philadelphia positive disease (9;22 translocation at location of BCR-ABL1 fusion); Loss of CD19 expressions.