IL-21 Expanded Natural Killer Cells for Leukemia

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Sumithira Vasu, MBBS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Sumithira Vasu

No Placebo Group

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.

Research Team

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

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

Treatment Details

Interventions

• Membrane-bound Interleukin-21-Expanded Haploidentical Natural Killer Cells (NK Cell Therapy)

Trial Overview The 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

Group I: Induction Experimental Treatment 1 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 Regimen Experimental Treatment 2 Interventions

Fludarabine 30 mg/m2/day (day -6 to day -2) and Cytarabine 2g/ m2/day (days -6 to day -2)

Who Is Running the Clinical Trial?

Sumithira Vasu

Lead Sponsor

Trials

6

Recruited

140+

Kiadis Pharma

Industry Sponsor

Trials

12

Recruited

540+