BLinatumomab and iNKT in Relapsed B-Cell ALL

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT07869368
Phase
PHASE1
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • ALL (Acute B-Lymphoblastic Leukemia)
  • B-Cell ALL
  • CD19-positive B-cell Acute
  • Philadelphia Chromosome-Negative Lymphoblastic Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Invariant Natural Killer T Cell Therapy — BIOLOGICAL
    AgenT-797 is an investigational invariant natural killer T (iNKT) cell therapy administered as a single intravenous infusion in combination with blinatumomab.

Study Details

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.

Key Dates

First listed
Oct 9, 2026
Start date
Oct 31, 2026
Status verified
Oct 2026
Primary completion
Feb 28, 2029
Completion
Feb 28, 2030

Study Design

Enrollment
13 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Blinatumomab-resistant/progressive B-ALL
    Patients with CD19-positive, Philadelphia chromosome-negative B-ALL with disease progression during blinatumomab therapy, including patients who become MRD-positive after achieving prior MRD negativity or who experience frank relapse.

Primary Outcome Measure

Number of participants with Grade 3 or higher Treatment Related Adverse Events -CTCAE [ Time Frame: Up to 9 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599
Ginna Manzanares
[email protected]
Ashley Romo
[email protected]

Find similar trials in Chapel Hill, NC

By research site
UNC Lineberger Comprehensive Cancer Center· Chapel Hill, NC

Related Studies