19 Participants Needed

IL-21 Expanded Natural Killer Cells for Leukemia

Recruiting at 1 trial location
TO
NS
Overseen ByNicole Szuminski
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This phase I trial studies the side effects of donor natural killer (NK) cell therapy in treating patients with acute myeloid leukemia that has come back (recurrent) or has not responded to treatment (refractory). Natural killer cells are a type of immune cell. Immunotherapy with genetically modified NK cells from donors may induce changes in the body's immune system and may interfere with the ability of cancer cells to grow and spread.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on any concurrent therapy like chemotherapy, targeted therapy, radiation therapy, or immunotherapy for your leukemia while participating in this trial.

What data supports the effectiveness of the treatment Membrane-bound Interleukin-21-Expanded Haploidentical Natural Killer Cells for leukemia?

Research shows that natural killer (NK) cells expanded with membrane-bound interleukin-21 (IL-21) can grow significantly and become highly effective at killing cancer cells, including leukemia cells. In clinical trials, these expanded NK cells have been shown to improve patient outcomes by reducing relapse rates and increasing survival in leukemia patients.12345

Is the treatment with IL-21 expanded NK cells safe for humans?

In clinical trials, IL-21 expanded NK cells have been shown to be safe for humans, with no serious side effects or dose-limiting toxicities reported. Patients receiving these cells after stem cell transplantation experienced low rates of complications and improved immune function.45678

How is the treatment with IL-21 Expanded Natural Killer Cells for Leukemia different from other treatments?

This treatment uses natural killer (NK) cells expanded with membrane-bound interleukin-21 (IL-21), which allows for a large-scale production of highly active NK cells. These cells are more effective in targeting leukemia cells compared to traditional methods, and the treatment is designed to reduce the risk of leukemia relapse after stem cell transplantation.13456

Research Team

SV

Sumithira Vasu, MBBS

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

This trial is for adults with recurrent or treatment-resistant acute myeloid leukemia (AML) who weigh at least 42 kg, have a decent heart function and performance status, controlled seizures if present, acceptable liver and kidney functions, no active graft-versus-host disease or uncontrolled infections. They must not be on high-dose steroids or have had recent investigational therapies.

Inclusion Criteria

Patient weight ≥ 42 kg
Patients on hydrocortisone for adrenal insufficiency or on inhaled or topical steroids are eligible
Primary Relapsed AML including Relapsed AML after allogeneic stem cells
See 12 more

Exclusion Criteria

Any comorbidities that in the opinion of the investigator will preclude receiving fludarabine or cytarabine
Active GVHD
Prednisone dose is > 20 mg/day or >0.25mg/kg, whichever is higher will be excluded
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Patients receive fludarabine and cytarabine, followed by six doses of NK cells

3 weeks
Multiple visits for infusions

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks
Regular monitoring visits

Treatment Details

Interventions

  • Membrane-bound Interleukin-21-Expanded Haploidentical Natural Killer Cells
Trial OverviewThe trial is testing the safety of donor natural killer (NK) cells that are expanded using membrane-bound Interleukin-21 to treat AML. These genetically modified NK cells may help the immune system stop cancer growth and spread.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: InductionExperimental Treatment1 Intervention
Six doses of third-party-donor mbIL-21 expanded (KDS-1001) cells given thrice weekly for two weeks. Days may vary and KDS-1001 can be given from days 0 to 21
Group II: Conditioning RegimenExperimental Treatment2 Interventions
Fludarabine 30 mg/m2/day (day -6 to day -2) and Cytarabine 2g/ m2/day (days -6 to day -2)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sumithira Vasu

Lead Sponsor

Trials
6
Recruited
140+

Kiadis Pharma

Industry Sponsor

Trials
12
Recruited
540+

Findings from Research

The phase 1 study involving 7 patients with refractory/relapsed acute myeloid leukemia (AML) demonstrated that adoptive transfer of activated NK cells (aNK) is safe, with no dose-limiting toxicities or severe adverse effects observed during treatment or the 21-day follow-up period.
While the aNK cell therapy showed transient activity in 3 out of 7 patients, the study confirmed the feasibility of using 'off-the-shelf' aNK cells, paving the way for future combination immunotherapy trials to enhance treatment for AML.
Phase 1 clinical trial of adoptive immunotherapy using "off-the-shelf" activated natural killer cells in patients with refractory and relapsed acute myeloid leukemia.Boyiadzis, M., Agha, M., Redner, RL., et al.[2018]

References

Expansion of highly cytotoxic human natural killer cells for cancer cell therapy. [2022]
Recipient T Cell Exhaustion and Successful Adoptive Transfer of Haploidentical Natural Killer Cells. [2019]
Cellular therapy: Adoptive immunotherapy with expanded natural killer cells. [2020]
Phase 1 clinical trial using mbIL21 ex vivo-expanded donor-derived NK cells after haploidentical transplantation. [2021]
Membrane bound IL-21 based NK cell feeder cells drive robust expansion and metabolic activation of NK cells. [2021]
[Effects of humanized interleukin 21 on anti-leukemic activity of cytokine induced killer cells and the mechanism]. [2018]
Decrease post-transplant relapse using donor-derived expanded NK-cells. [2022]
Phase 1 clinical trial of adoptive immunotherapy using "off-the-shelf" activated natural killer cells in patients with refractory and relapsed acute myeloid leukemia. [2018]