DNT Cells for Myeloid Leukemia

Overseen By Mark Minden, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University Health Network, Toronto

Must not be taking: Cox2 inhibitors, Corticosteroids

Disqualifiers: Persistent infection, Active CNS disease, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Duration not specified

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of a new cell therapy for people with high-risk acute myeloid leukemia (AML), a type of blood cancer. The treatment uses special immune cells, called Double Negative T cells (DNT cells), taken from healthy donors to target and fight leukemia cells. Eligible participants have AML, are currently in remission, and are receiving ongoing treatment. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking Cox2 inhibitors and corticosteroids for at least 3 days before and 7 days after the infusion of DNT cells. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

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

A previous study found that a new treatment using special immune cells called double-negative T (DNT) cells was safe for patients with relapsed acute myeloid leukemia (AML). Research shows that these cells can effectively target AML without causing graft-versus-host disease, a common side effect of some treatments. Another study found that this DNT cell therapy led to a 50% complete remission rate in patients, demonstrating its potential. While these results are promising, it is important to remember that this is early research. The main focus is on understanding how safe and well-tolerated DNT cells are in people with high-risk AML. ^{1 2 3 4 5}

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

Researchers are excited about DNT cells for treating myeloid leukemia because these cells offer a novel approach compared to traditional methods like chemotherapy and targeted therapies. Unlike existing treatments, DNT cells are derived from healthy donors and are designed to specifically target and kill cancer cells without harming normal cells. This targeted action could potentially lead to fewer side effects and improved outcomes for patients. Additionally, DNT cells harness the body's immune system to fight the cancer, representing a promising new avenue for treatment.

What evidence suggests that DNT cells might be an effective treatment for acute myeloid leukemia?

Research has shown that Double Negative T (DNT) cells, a type of immune cell, may help fight acute myeloid leukemia (AML). In previous studies, DNT cells from healthy donors helped five out of ten patients achieve complete remission, meaning their cancer was no longer detectable. In this trial, patients will receive DNT cells from healthy donors. These cells can kill leukemia cells without harming healthy tissue by specifically targeting and destroying leukemia cells through certain processes inside the cell. These early findings suggest that DNT cells could be a powerful tool against AML. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with high-risk acute myeloid leukemia (AML) who are in remission after specific induction therapy. They must have normal liver and kidney function tests, agree to use contraception or abstain from sex, and be able to follow the study procedures until all DNT cells are out of their system.

Inclusion Criteria

Your creatinine level must be within a certain range before starting the study treatment.

I will use condoms or not have sex from the start of chemotherapy until a month after it ends.

I have frozen cells from my diagnosis or relapse for testing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive incremental doses of Double Negative T (DNT) cells from healthy donors

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment, including monitoring of leukemia load and adverse events

2 years

What Are the Treatments Tested in This Trial?

Interventions

• DNT cells

Trial Overview The trial is testing the safety of injecting Double Negative T (DNT) cells into AML patients. These cells come from healthy donors and could help fight cancer. The study will gradually increase doses to find a safe level.

How Is the Trial Designed?

Group I: Patient Arm Experimental Treatment 1 Intervention

Patients will receive DNT cells from healthy donors.

Group II: Donor Arm Active Control 1 Intervention

Healthy volunteer donors will donate blood.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Ozmosis Research Inc.

Industry Sponsor

Trials

25

Recruited

5,200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8533698/

Enhancing Therapeutic Efficacy of Double Negative T Cells ... AML is the most common form of adult acute leukemia with a poor overall 5-year survival rate of 30–45% for patients 60 years old or younger and 10–15% for ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1471489225000335

Allogeneic double-negative T-cell therapy for acute ... All patients received three complete DNT infusions as planned. Among the ten patients treated, five achieved complete remission (two with incomplete hematologic ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4214360/

Anti leukemia effect of ex vivo expanded DNT cells from AML ... The expanded DNT cells could effectively kill both allogeneic and autologous primary CD34+ leukemic blasts isolated from peripheral blood of AML patients in a ...

4. aacrjournals.org aacrjournals.org/clincancerres/article/24/2/370/122952/Allogeneic-Human-Double-Negative-T-Cells-as-a

Allogeneic Human Double Negative T Cells as a Novel ... Together, these results demonstrate that ex vivo expanded allogeneic DNTs have potent antileukemic effects but are noncytotoxic to normal tissues and ...

5. ashpublications.org ashpublications.org/bloodadvances/article/8/12/3013/515528/Double-negative-T-cells-utilize-a-TNF-JAK1-ICAM-1

Double-negative T cells utilize a TNFα–JAK1–ICAM-1 ... A phase 1 clinical trial demonstrated the feasibility, safety, and potential efficacy of allogeneic DNT therapy among patients with relapsed AML ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38547431/

Double-negative T cells utilize a TNFα-JAK1-ICAM-1 ... A phase 1 clinical trial demonstrated the feasibility, safety, and potential efficacy of allogeneic DNT therapy among patients with relapsed AML ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12224462/

Prophylactic infusion of allogeneic double-negative T cells ... Our Phase I clinical trial (ChiCTR-1900022795) demonstrated that DNT therapy induced 50% complete remission (CR) rate in relapsed AML patients ...