NKTR-255 vs Placebo Following CD19-directed CAR-T Therapy in Patients With Relapsed/Refractory Large B-cell Lymphoma

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Non-Hodgkin Lymphoma, Relapsed/Refractory Diffuse Large B-cell Lymphoma

In brief

This study will evaluate the safety and efficacy of NKTR-255 following CD19-directed chimeric antigen (CAR)-T cell therapy in patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL). NKTR-255 is an investigational IL-15 receptor agonist designed to boost the immune system's natural ability to fight cancer. T cells are infection fighting blood cells that can kill tumor cells. Chimeric antigen (CAR)-T cell product consists of genetically engineered T-cells, modified to recognize CD19, a protein on the surface of cancer cells. These CD19-specific T cells may help the body's immune system identify and kill CD19-positive cancer cells. Giving NKTR-255 following the treatment with CD19 CAR-T cell therapy may work better in treating large B-cell lymphoma than either drug alone.

Key facts

Study ID

NCT05664217

Run by

Nektar Therapeutics

People needed

15

Starts

2022-12-23

Expected to finish

2024-08-16

Last updated by the study team

2025-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Use of therapeutic doses of corticosteroids (≥ 5 mg/day prednisone or equivalent) or other systemic immunosuppression within 7 days prior to leukapheresis or within 72 hours prior to CAR-T cell infusion. Topical and/or inhaled steroids are permitted.
• Prior treatment with any CD19-directed CAR-T cell therapy other than the treatment planned per Inclusion Criterion 2.
• For allogeneic hematopoietic cell transplant recipients, active graft versus host disease (GVHD) and/or systemic GVHD therapy during screening or up to 30 days prior to leukapheresis.
• Known active hepatitis B (detectable hepatitis B DNA) or hepatitis C (detectable hepatitis C RNA).
• Known human immunodeficiency virus (HIV) infection.
• Pregnant or breastfeeding women.
• Prior treatment with any IL-2 or IL-15 agonist and/or biosimilar agents.
• Active autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, ulcerative colitis, Crohn's disease], celiac disease, or other serious chronic gastrointestinal conditions associated with diarrhea, autoimmune vasculitis, systemic lupus erythematosus, Wegener syndrome [granulomatosis with polyangiitis], myasthenia gravis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.) within 1 year prior to randomization. The following are exceptions to this criterion:
• Vitiligo
• Alopecia
• Hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement
• Type 1 diabetes mellitus
• Psoriasis not requiring systemic treatment
• Conditions considered to be low risk of serious deterioration by the Investigator and with Medical Monitor approval
• History of any one of the following cardiovascular conditions within the 6 months prior to randomization: class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, or unstable angina; unless clearance by a cardiologist is obtained. History of other clinically significant cardiac disease that, in the opinion of the Investigator or designee, is a contraindication to study treatment is also excluded.
• History or presence of clinically relevant central nervous system (CNS) pathology, such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, or psychosis that in the opinion of the Investigator is a contraindication to study treatment.
• History of CNS lymphoma, primary CNS lymphoma, brain metastases, or detectable malignant cells in the cerebrospinal fluid.
• History of solid organ transplantation.
• Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the Medical Monitor.
• Presence of any indwelling line or drain (eg, percutaneous nephrostomy tube, indwelling foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter). Dedicated central venous access catheters such as a Port-a-Cath or Hickman catheter are permitted.
• Active or current participation on any other interventional studies.
• Use of an investigational agent or an investigational device within 28 days of CAR-T cell therapy.
• Live, attenuated vaccines are prohibited within 30 days of randomization.
• Any condition including medical, emotional, psychiatric, or logistical that, in the opinion of the Investigator, would preclude the patient from adhering to the protocol or would increase the risk associated with study participation or study drug administration or interfere with the interpretation of results.

Where it is running

• University of California San Diego — La Jolla, California, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• University Of Iowa Hospitals & Clinics — Iowa City, Iowa, United States
• University of Kansas Cancer Center — Fairway, Kansas, United States
• University of Maryland — Baltimore, Maryland, United States
• UMass Memorial Medical Center — Worcester, Massachusetts, United States
• Saint Louis University — St Louis, Missouri, United States
• Washington University School of Medicine in St. Louis — St Louis, Missouri, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• NYU Langone Medical Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Novant Health Cancer Institute — Charlotte, North Carolina, United States
• Novant Health Cancer Institute - Winston-Salem — Winston-Salem, North Carolina, United States
• Oncology Hematology Care Inc - Cincinnati — Cincinnati, Ohio, United States
• Penn State Health Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Allegheny Health Network — Pittsburgh, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Intermountain Healthcare — Salt Lake City, Utah, United States
• Fred Hutchinson/University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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