Stage 1 NKTR-255 at 3.0 μg/kg for Diffuse Large B-Cell Lymphoma (DLBCL)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Diffuse Large B-Cell Lymphoma (DLBCL)+1 MoreNKTR-255 at 3.0 μg/kg - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Diffuse Large B-Cell Lymphoma (DLBCL)
  • Non-Hodgkin's Lymphoma

Treatment Effectiveness

Study Objectives

2 Primary · 9 Secondary · Reporting Duration: Up to 3 years

Month 3
Complete response (CR) rate at month 3
Objective response rate (ORR) at month 3
Month 6
Complete response (CR) rate at month 6
Objective response rate (ORR) at month 6
Day 30
Incidence of treatment-emergent adverse events (AEs) and laboratory abnormalities by type and severity.
Year 3
Duration of Response (DOR)
Up to 3 years
Best overall Complete response (CR) rate
Best overall objective response rate (ORR)
Overall Survival (OS)
Progression-Free Survival (PFS)
Year 3
Event-free survival (EFS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

4 Treatment Groups

Stage 1 NKTR-255 at 3.0 μg/kg
1 of 4
Stage 1 NKTR-255 at 1.5 µg/kg
1 of 4
Stage 1 NKTR-255 at 3.0/6.0 μg/kg
1 of 4
Placebo
1 of 4

Experimental Treatment

Non-Treatment Group

400 Total Participants · 4 Treatment Groups

Primary Treatment: Stage 1 NKTR-255 at 3.0 μg/kg · Has Placebo Group · Phase 2 & 3

Stage 1 NKTR-255 at 3.0 μg/kg
Drug
Experimental Group · 1 Intervention: NKTR-255 at 3.0 μg/kg · Intervention Types: Drug
Stage 1 NKTR-255 at 1.5 µg/kg
Drug
Experimental Group · 1 Intervention: NKTR-255 at 1.5 µg/kg · Intervention Types: Drug
Stage 1 NKTR-255 at 3.0/6.0 μg/kg
Drug
Experimental Group · 1 Intervention: NKTR-255 at 3.0/6.0 μg/kg · Intervention Types: Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo Comparator · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years

Who is running the clinical trial?

Nektar TherapeuticsLead Sponsor
54 Previous Clinical Trials
9,723 Total Patients Enrolled
Study DirectorStudy DirectorNektar Therapeutics
1,073 Previous Clinical Trials
475,967 Total Patients Enrolled
2 Trials studying Diffuse Large B-Cell Lymphoma (DLBCL)
191 Patients Enrolled for Diffuse Large B-Cell Lymphoma (DLBCL)

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are an adult of any gender age 18 or above.
You suffer from a disease that did not respond to first-line chemoimmunotherapy, or relapsed within 12 months of receiving it.
You have an unresponsive condition to initial chemoimmunotherapy or recurrence after first-line chemoimmunotherapy and are not suitable for HSCT due to comorbidities or age.
You have experienced a recurrence of the condition or an unresponsiveness to treatment after having received at least two different therapies.
You have not responded to initial chemotherapy and immunotherapy treatments.
You have relapsed within 12 months of first-line chemoimmunotherapy, or you are R/R LBCL after 2 lines of systemic therapy, including DLBCL not otherwise specified, primary mediastinal LBLC, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.
You are an adult patient with relapsed or refractory Large B-Cell Lymphoma (LBLC) who have had two prior lines of systemic therapy, which may include Diffuse Large B-Cell Lymphoma Not Otherwise Specified (DLBCL NOS), High Grade B-cell Lymphoma and DLBCL arising from Follicular Lymphoma.
You have received a lymphodepleting chemotherapy regimen according to the respective FDA (or SmPC) label for CAR-T cell therapy.
You have FDG-active disease evidenced on PET imaging within the past month prior to receiving CAR-T cell therapy.
There is/are FDG-avid lesion(s) on PET/CT scans post bridging therapy before lymphodepletion, as necessary.