RecruitingPhase 1NCT04848064

Third-Party Natural Killer Cells and Mogamulizumab for the Treatment of Relapsed or Refractory Cutaneous T-cell Lymphomas or Adult T-Cell Leukemia/Lymphoma

A Pilot Phase I Trial of IL-21 Expanded, Off the Shelf, Third-Party Natural Killer (NK) Cells in Combination With Mogamulizumab in Patients With Cutaneous T-Cell Lymphomas or Adult T-Cell Leukemia/Lymphomas


Sponsor

John Reneau

Enrollment

12 participants

Start Date

May 6, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial is to find out the best dose, possible benefits and/or side effects of third-party natural killer cells in combination with mogamulizumab in treating patients with cutaneous T-cell lymphoma or adult T-cell leukemia/lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Immunotherapy with third-party natural killer cells, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Mogamulizumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving third-party natural killer cells in combination with mogamulizumab may kill more cancer cells.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of natural killer (NK) cell therapy — immune cells from a donor, engineered to attack cancer — together with a targeted antibody drug (mogamulizumab) for people with relapsed or treatment-resistant cutaneous T-cell lymphoma (a rare skin cancer) or adult T-cell leukemia/lymphoma. **You may be eligible if:** - You are 18 or older - You have cutaneous T-cell lymphoma (stage IB–IVB) that has returned or stopped responding after at least one prior systemic therapy, OR adult T-cell leukemia/lymphoma that has been treated with at least one prior chemotherapy - You are in good overall health (ECOG 0–1) - Your blood counts, kidney, and liver function meet minimum requirements - Your life expectancy is at least 90 days **You may NOT be eligible if:** - Your lymphoma has spread to the brain or spinal fluid - You have active serious infections, active hepatitis B or C, or HIV with CD4 count below 350 - You have had a solid organ transplant - You have previously received mogamulizumab for reasons other than disease progression - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCyclophosphamide

Given IV

DRUGFludarabine

Given IV

BIOLOGICALMogamulizumab

Given IV

BIOLOGICALNatural Killer Cell Therapy

Given via infusion

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies


Locations(1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04848064