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

Active:	Yes
Cancer Type:	Hematopoietic Malignancies Lymphoma Non-Hodgkin Lymphoma Unknown Primary	NCT ID:	NCT05664217
Trial Phases:	Phase II Phase III	Protocol IDs:	18-255-01 (primary) NCI-2023-02609
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Nektar
NCI Full Details:	http://clinicaltrials.gov/show/NCT05664217

Summary

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.

Objectives

Patients will be treated with lymphodepletion chemotherapy (as recommended by the CAR-T
cell manufacturer) and soon after will receive a one-time CD19-directed CAR-T cell
infusion (as per product label). Study drug (NKTR-255 or placebo) will be administered
intravenously approximately 14 days after CAR-T cell infusion and administered every 3
weeks for up to 7 cycles or 5 months (whichever is earlier) in the absence of disease
progression or unacceptable toxicity. After completion of study treatment, patients will
be followed-up at 30 days, and then at 9,12,18, 24, and 36 months after CAR-T cell
infusion.

The study will be conducted in two stages: Stage 1 (Phase II) is expected to complete the
enrollment of 56 patients by the end of 2023. Primary endpoint data will be available in
the second half of 2024. Stage 2 (Phase III) is expected to initiate before the end of
2024.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.