BLinatumomab and iNKT in Relapsed B-Cell ALL

NCT07869368 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: LCCC2608
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Residual disease; disease progression; progressive disease; genT-797; natural killer T-cell (iNKT) therapy; cell therapy; natural killer cell therapy

Outcome Measures

Primary Outcomes (3)

• Number of participants with Grade 3 or higher Treatment Related Adverse Events -CTCAE

  Number of participants with Grade 3 or higher Treatment Related Adverse Events based on The NCI Common Terminology Criteria for Adverse Events (CTCAE) will be reported. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.

  Up to 9 months

• Number of participants with Grade 3 or higher Treatment Related Adverse Events - cytokine release syndrome (CRS)

  CRS will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading. Grade 1 - Mild: Fever ≥38\^ o C, No hypotension, No hypoxia, Grade 2 - Moderate: Fever ≥38\^ o C, Hypotension not requiring vasopressors, Hypoxia requiring low-flow nasal cannula (≤6 L/minute) or blow-by, Grade 3 - Severe: Fever ≥ 38\^ o C, Hypotension requiring a vasopressor with or without vasopressin, Hypoxia requiring high-flow nasal cannula (\>6 L/minute), facemask, nonrebreather mask, or Venturi mask, Grade 4 - Life-threatening: Fever ≥38\^oC, Hypotension requiring multiple vasopressors (excluding vasopressin), Hypoxia requiring positive pressure (e.g. Continuous positive airway pressure, BiPAP, intubation, mechanical ventilation), Grade 5 - Death

  Up to 9 months

• Number of participants with Grade 3 or higher Treatment Related Adverse Events - Neurological Toxicity (ICANS)

  Immune effector cell-associated neurotoxicity syndrome (ICANS) symptoms will be graded according to the criteria outlined in the protocol on a scale from 1 (mild) to 4 (critical). Cytokine release syndrome (CRS) will be graded according to criteria outlined in the protocol on a scale from 1 (mild) to grade 5 (death).

  Up to 9 months

Secondary Outcomes (5)

• The effectiveness of the combination therapy

  Up to 9 months

• Extramedullary disease response

  Up to 42 days (after Cycle 1)

• Change in residual B-cell acute lymphoblastic leukemia (B-ALL)

  Up to 9 months

• Event-Free Survival (EFS)

  Up to 18 months

• Overall Survival (OS)

  Up to 18 months

Study Arms (1)

Blinatumomab-resistant/progressive B-ALL

EXPERIMENTAL

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.

Biological: Invariant Natural Killer T Cell Therapy

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.

Blinatumomab-resistant/progressive B-ALL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Loss of CD19 expressions.
• 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 concurrent leukemia-directed therapy

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• MiNK Therapeutics: collaborator

Study Sites (1)

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Burkitt Lymphoma; Neoplasm, Residual; Disease Progression

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Lacey S Williams, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ginna Manzanares

CONTACT

919-984-0000; ginna_manzanares@med.unc.edu

Ashley Romo

CONTACT

919-984-0000; ashley_romo@med.unc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2026
• First Posted: October 9, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2030
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)