Invariant Natural Killer T Cell Therapy + Blinatumomab for Acute Lymphoblastic Leukemia

(BLINK B-ALL Trial)

GM
AR
Overseen ByAshley Romo
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: UNC Lineberger Comprehensive Cancer Center
Must be taking: Blinatumomab
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment combination for individuals with B-cell acute lymphoblastic leukemia (B-ALL). It tests the safety and effectiveness of an experimental therapy called agenT-797 when used with blinatumomab in patients whose cancer has resisted or progressed despite blinatumomab treatment. This includes those whose cancer returned or worsened after initially responding to treatment. Suitable candidates for this trial have B-cell ALL and have experienced a return of cancer signs after remission or worsening during blinatumomab treatment. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that agenT-797 has undergone testing in several studies to assess its safety and tolerability. In studies involving patients with solid tumors and other serious illnesses, agenT-797 has generally been well-tolerated. These studies have not reported any severe side effects directly linked to the treatment, suggesting that agenT-797 is likely safe.

This trial is in its early stages, focusing primarily on evaluating safety and tolerability. While earlier research is encouraging, the safety of using agenT-797 with blinatumomab remains under careful study. Participants will receive close monitoring to minimize any risks.12345

Why do researchers think this study treatment might be promising for acute lymphoblastic leukemia?

Unlike the standard treatments for acute lymphoblastic leukemia (ALL), which often include chemotherapy and immunotherapy drugs like blinatumomab, agenT-797 offers a fresh approach by harnessing invariant natural killer T (iNKT) cells. Researchers are excited about this therapy because iNKT cells have a unique ability to target and destroy cancer cells while potentially reducing the risk of relapse. This mechanism could provide new hope for patients resistant to existing therapies, offering a much-needed alternative for those with progressive forms of the disease.

What evidence suggests that this treatment might be an effective treatment for acute lymphoblastic leukemia?

Research has shown that agenT-797, an immune therapy using special cells called iNKT cells, holds promise for treating various cancers. In an earlier study, it helped a patient with advanced cancer achieve complete remission, demonstrating strong cancer-fighting abilities. It also boosts the immune system, which is crucial for attacking cancer cells. Although limited information exists about its use in acute lymphoblastic leukemia (ALL), these results suggest it could effectively target cancer cells. This trial explores agenT-797 as a potential treatment for challenging cases of ALL that have not responded to other treatments, offering an exciting option for participants.25678

Who Is on the Research Team?

LS

Lacey S Williams, MD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for people with Philadelphia chromosome-negative, CD19-positive B-cell acute lymphoblastic leukemia (B-ALL) who have relapsed or their disease has worsened after treatment with blinatumomab. Participants must meet specific medical criteria set by the study team.

Inclusion Criteria

Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee
I have been diagnosed with B-cell acute lymphoblastic leukemia.
Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information
See 2 more

Exclusion Criteria

I am currently receiving other treatments for leukemia.
My cancer cells no longer have CD19 protein.
I have active leukemia in my central nervous system.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive agenT-797 in combination with blinatumomab to assess safety and tolerability

Up to 9 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 18 months

What Are the Treatments Tested in This Trial?

Interventions

  • agenT-797

Trial Overview

The study tests a new immune cell therapy called agenT-797 (iNKT cells) given together with standard care blinatumomab in patients whose leukemia returned or progressed. All participants receive both treatments; there is no placebo group.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Blinatumomab-resistant/progressive B-ALLExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials
377
Recruited
95,900+

MiNK Therapeutics

Industry Sponsor

Trials
3
Recruited
70+

Citations

MiNK Therapeutics' AgenT-797 Shows Promising Results ...

In a cohort of 21 patients with mechanical ventilation, survival rates exceeded 70%, with a remarkable 80% survival rate among those (5) on VV ...

AgenT-797 - Drug Targets, Indications, Patents

We report an unprecedented complete remission in a heavily pre-treated metastatic germ cell neoplasm, using ex vivo expanded allogeneic iNKT ...

MiNK Therapeutics to Present Updated Clinical Data of allo ...

Clinical update of allo-iNKT cells (agenT-797) alone or in combination with approved anti-PD-1 in advanced solid tumors.

Poster 647

agent-797 is tolerated at all dose levels tested and no MTD has been • TEAEs were observed in 8/12 subjects; the most common were fatigue (n=3) ...

5.

investor.minktherapeutics.com

investor.minktherapeutics.com/node/7996/pdf

February 12, 2025

The oral presentation will highlight interim data from the company's ongoing Phase 2 study testing AgenT-797

6.

investor.minktherapeutics.com

investor.minktherapeutics.com/node/6686/pdf

November 9, 2021

Taken together, these data underscore the potential of agenT-797 in solid tumors, liquid malignancies, and life-threatening infectious diseases.

AGENT-797 - Multiple Myeloma Clinical Trials

This is a Phase 1, open-label study to explore the safety, tolerability, and preliminary clinical activity of agenT-797, an unmodified, ...

AgenT-797 Demonstrates Potential in Treating Severe ...

AGENT-797, a product candidate currently undergoing multiple Phase 1 clinical trials.