B-Cell ALLPhase 1BLINK B-ALLNCT07869368
BLinatumomab and iNKT in Relapsed B-Cell ALL
A Phase 1 study testing Invariant Natural Killer T Cell Therapy in people with B-Cell ALL and ALL (Acute B-Lymphoblastic Leukemia), run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-Cell ALL, ALL (Acute B-Lymphoblastic Leukemia), Philadelphia Chromosome-Negative Lymphoblastic Leukemia
- What is being tested?
- Invariant Natural Killer T Cell Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Feb 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Ginna Manzanares, ginna_manzanares@med.unc.edu
Ashley Romo, ashley_romo@med.unc.edu
About this study
Official title: 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.
- Conditions
- B-Cell ALL, ALL (Acute B-Lymphoblastic Leukemia), Philadelphia Chromosome-Negative Lymphoblastic Leukemia, CD19-positive B-cell Acute
- Being tested
- Invariant Natural Killer T Cell Therapy
- Keywords
- Residual disease, disease progression, progressive disease, genT-797, natural killer T-cell (iNKT) therapy, cell therapy, natural killer cell therapy
- Medical subject headings
- Burkitt Lymphoma, Neoplasm, Residual, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invariant Natural Killer T Cell TherapyBiological
AgenT-797 is an investigational invariant natural killer T (iNKT) cell therapy administered as a single intravenous infusion in combination with blinatumomab.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Invariant Natural Killer T Cell Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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).
Measured: Up to 9 months
Secondary outcomes (5)
The effectiveness of the combination therapy
The effectiveness of the combination therapy will be evaluated according to disease status at study entry. Among participants with frank hematologic relapse, efficacy will be defined as a reduction in bone marrow leukemic blasts to <5% after the first cycle of combination therapy. Among participants with measurable residual disease (MRD) without frank relapse, efficacy will be assessed by the proportion of participants achieving MRD negativity by multiparameter flow cytometry and/or demonstrating a decrease in MRD level from baseline. Among participants with extramedullary disease, efficacy will be assessed by the proportion achieving PET negativity after therapy and, where applicable, by changes in physical examination measurements of skin or superficial extramedullary involvement.
Measured: Up to 9 months
Extramedullary disease response
Extramedullary disease response is defined by resolution of Positron Emission Tomography (PET)-detectable disease on Positron Emission Tomography/Computed Tomography (PET/CT) imaging for participants with PET-avid extramedullary disease at baseline, or reduction in the size of skin or other superficial extramedullary lesions based on physical examination.
Measured: Up to 42 days (after Cycle 1)
Change in residual B-cell acute lymphoblastic leukemia (B-ALL)
Change in residual B-cell acute lymphoblastic leukemia (B-ALL) detected by the clonoSEQ assay, measured by immunoglobulin sequence tracking from baseline to follow-up in participants with available diagnostic samples. ClonoSEQ® assay is a laboratory test used to detect and tracking unique leukemia cell DNA sequences.
Measured: Up to 9 months
Event-Free Survival (EFS)
Event-Free Survival (EFS) is defined as the time from treatment initiation to MRD relapse, clinical relapse, disease progression, or death. Participants will be followed for up to 7 months through study assessments and up to 18 months through medical record review.
Measured: Up to 18 months
Overall Survival (OS)
Overall Survival (OS) is defined as the time from treatment initiation to death from any cause. Participants will be followed for up to 18 months after study initiation.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-Cell ALLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- MiNK Therapeutics
- Responsible party
- Sponsor
- Investigators
- Lacey S Williams, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869368
- Sponsor's protocol ID
- LCCC2608
- Acronym
- BLINK B-ALL
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data may be shared with approved researchers and industry partners one year after completion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BLINKB-ALL: BLinatumomab and iNKT in Relapsed B-Cell ALL
- ClinicalTrials.gov ID
- NCT07869368
- Acronym / sponsor ID
- BLINK B-ALL / LCCC2608
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- MiNK Therapeutics
- Study start
- Oct 2026 (estimated)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blinatumomab-resistant/progressive B-ALL | Experimental | Biological: Invariant Natural Killer T Cell TherapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invariant Natural Killer T Cell TherapyAgenT-797 is an investigational invariant natural killer T (iNKT) cell therapy administered as a single intravenous infusion in combination with blinatumomab. | Biological | Blinatumomab-resistant/progressive B-ALL |
Primary outcome
Number of participants with Grade 3 or higher Treatment Related Adverse Events -CTCAE
Time frame: Up to 9 months
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.
Number of participants with Grade 3 or higher Treatment Related Adverse Events - cytokine release syndrome (CRS)
Time frame: Up to 9 months
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
Number of participants with Grade 3 or higher Treatment Related Adverse Events - Neurological Toxicity (ICANS)
Time frame: Up to 9 months
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).
5 secondary outcomes
The effectiveness of the combination therapy
Time frame: Up to 9 months
Extramedullary disease response
Time frame: Up to 42 days (after Cycle 1)
Change in residual B-cell acute lymphoblastic leukemia (B-ALL)
Time frame: Up to 9 months
Event-Free Survival (EFS)
Time frame: Up to 18 months
Overall Survival (OS)
Time frame: Up to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified data may be shared with approved researchers and industry partners one year after completion of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lacey S Williams, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Invariant Natural Killer T Cell Therapy in people with B-Cell ALL and ALL (Acute B-Lymphoblastic Leukemia), run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ginna Manzanares (919-984-0000, ginna_manzanares@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Grade 3 or higher Treatment Related Adverse Events -CTCAE (time frame: Up to 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.