NCT07869368Not yet recruitingPhase 1
BLinatumomab and iNKT in Relapsed B-Cell ALL
BLINKB-ALL: BLinatumomab and iNKT in Relapsed B-Cell ALL
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 13 (estimated)
- First submitted
- 30 Sept 2026
- Start date
- Oct 2026
- Primary completion date
- Feb 2029
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Diseases
- Acute lymphoblastic leukaemia
- NCT number
- NCT07869368
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 13
- From Oct 2026 to the primary completion date, Feb 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other concurrent leukemia-directed therapy
Other illness
- 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)
Other
- Loss of CD19 expressions.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UNC Lineberger Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.