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

7 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to determine the safety and toxicity of incremental doses of Double Negative T (DNT) cells in human subjects with high risk acute myeloid leukemia (AML). DNT cells are mature T lymphocytes that comprise \~1% of white blood cells in humans. Injection of DNTs from healthy donors has been demonstrated to be effective against AML cells. DNT cells will be collected from healthy volunteers and injected into patients.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+