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Immune System Booster for Non-Hodgkin's Lymphoma

Phase 2 & 3
Recruiting
Research Sponsored by Nektar Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years

Summary

This trial will test if an immune system booster (NKTR-255) can help fight cancer after using a modified T-cell therapy (CD19 CAR-T) to treat relapsed/refractory large B-cell lymphoma.

Who is the study for?
Adults with relapsed/refractory large B-cell lymphoma who've had standard CAR-T cell therapy and specific chemotherapy. They must not have used certain immune therapies recently, have good organ function, and agree to contraception if of reproductive potential. Excluded are those with prior IL-15 agonist treatment, recent steroids or immunosuppression use, other CD19-directed CAR-T treatments, active infections like hepatitis/HIV, CNS lymphoma history, uncontrolled infections requiring IV drugs.
What is being tested?
The trial tests NKTR-255's effectiveness in enhancing the body's immune response after CD19-directed CAR-T cell therapy in patients with stubborn large B-cell lymphoma. It compares different doses of NKTR-255 against a placebo to see if it improves cancer-fighting outcomes.
What are the potential side effects?
While specific side effects for NKTR-255 aren't listed here, similar immune system boosters can cause flu-like symptoms (fever/chills), fatigue, injection site reactions and may affect blood counts or organ function.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Complete response (CR) rate at month 6
Event-free survival (EFS)
Secondary study objectives
Best overall Complete response (CR) rate
Best overall objective response rate (ORR)
Complete response (CR) rate at month 3
+6 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Stage 1 NKTR-255 at 3.0/6.0 μg/kgExperimental Treatment1 Intervention
In this arm of Stage 1 (Phase 2 of the study), patients will be dosed with 3.0 μg/kg NKTR-255 in Cycle 1 (C1) and continue in Cycle 2 and subsequent cycles (C+) with 6.0 μg/kg NKTR-255 (hereinafter referred to as 3.0/6.0 µg/kg NKTR-255). NKTR-255 will be administered intravenously approximately 14 days after CD19-directed CAR-T cell infusion. Patients will be dosed every 3 weeks for up to 7 cycles or 5 months, whichever is earlier, in the absence of disease progression or unacceptable toxicity. The dose regimen for Stage 2 (Phase 3 of the study) will be selected based on the results of Stage 1 as reviewed by the Data Monitoring Committee (DMC) and the study team.
Group II: Stage 1 NKTR-255 at 3.0 μg/kgExperimental Treatment1 Intervention
In this arm of Stage 1 (Phase 2 of the study), NKTR-255 will be dosed at 3.0 μg/kg. NKTR-255 will be administered intravenously approximately 14 days after CD19-directed CAR-T cell infusion. Patients will be dosed every 3 weeks for up to 7 cycles or 5 months, whichever is earlier, in the absence of disease progression or unacceptable toxicity. The dose regimen for Stage 2 (Phase 3 of the study) will be selected based on the results of Stage 1 as reviewed by the Data Monitoring Committee (DMC) and the study team.
Group III: Stage 1 NKTR-255 at 1.5 µg/kgExperimental Treatment1 Intervention
In this arm of Stage 1 (Phase 2 of the study), NKTR-255 will be dosed at 1.5 µg/kg. NKTR-255 will be administered intravenously approximately 14 days after CD19-directed CAR-T cell infusion. Patients will be dosed every 3 weeks for up to 7 cycles or 5 months, whichever is earlier, in the absence of disease progression or unacceptable toxicity. The dose regimen for Stage 2 (Phase 3 of the study) will be selected based on the results of Stage 1 as reviewed by the Data Monitoring Committee (DMC) and the study team.
Group IV: PlaceboPlacebo Group1 Intervention
Placebo is commercially available 0.9% Sodium Chloride Solution for Injection (USP). Placebo will be administered intravenously approximately 14 days after CD19-directed CAR-T cell infusion. Placebo will be infused every 3 weeks for up to 7 cycles or 5 months, whichever is earlier.

Find a Location

Who is running the clinical trial?

Nektar TherapeuticsLead Sponsor
58 Previous Clinical Trials
9,916 Total Patients Enrolled
Study DirectorStudy DirectorNektar Therapeutics
1,275 Previous Clinical Trials
498,785 Total Patients Enrolled

Media Library

Stage 1 NKTR-255 at 3.0 μg/kg Clinical Trial Eligibility Overview. Trial Name: NCT05664217 — Phase 2 & 3
B-Cell Lymphoma Research Study Groups: Stage 1 NKTR-255 at 3.0 μg/kg, Stage 1 NKTR-255 at 1.5 µg/kg, Stage 1 NKTR-255 at 3.0/6.0 μg/kg, Placebo
B-Cell Lymphoma Clinical Trial 2023: Stage 1 NKTR-255 at 3.0 μg/kg Highlights & Side Effects. Trial Name: NCT05664217 — Phase 2 & 3
Stage 1 NKTR-255 at 3.0 μg/kg 2023 Treatment Timeline for Medical Study. Trial Name: NCT05664217 — Phase 2 & 3
~208 spots leftby Jan 2027